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Reporting quality of randomized controlled trials of periodontal diseases in journal abstracts: a cross-sectional survey and bibliometric analysis

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REPORTING QUALITY OF RANDOMIZED CONTROLLED TRIALS OF PERIODONTAL DISEASES
IN JOURNAL ABSTRACTS – A CROSS-SECTIONAL SURVEY AND BIBLIOMETRIC ANALYSIS

By

Satish Kumar
_____________________________________________________________________________________________
A Thesis Presentation to the
FACULTY OF THE USC GRADUATE SCHOOL
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
MASTER OF SCIENCE
(CRANIOFACIAL BIOLOGY)

August 2015

Copyright 2015 Satish Kumar

DEDICATION

To my wife, Antonia Teruel, DDS, MS, PhD,
for her infinite love.
ii

ACKNOWLEDGMENT

My sincere gratitude goes to the following remarkable individuals without whom this project would not
have been so enjoyable to pursue.

Dr. Kian Kar - for his mentorship in this project and for serving as the chair of my thesis committee;
Drs. Michael Paine and Glenn Sameshima - for their support as my thesis committee members;
Dr. Husain Mohamad - for participating in this study as a second reviewer and contributing to valuable
discussions during the conception and conduct of the project;
Dr. Sarah Bushehri - for useful discussions on the conception of the project;
Ms. Hita Vora - for assistance with the statistical analysis and also her contagious enthusiasm and
brainstorming; and,
Dr. Antonia Teruel - for practical input on the usefulness of this project.
iii

TABLE OF CONTENTS

Dedication ii
Acknowledgment iii
List of Appendices v
List of Tables vi
List of Figures viii
Abstract 1
Chapter 1 Introduction 4
Chapter 2 Materials and Methods 8
Chapter 3 Results 11
Chapter 4 Discussion 49
Chapter 5 Conclusion 56
Bibliography 57
Appendix A Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomized
Controlled Trials in Journal and Conference Abstracts - Original Checklist (17 Items
with Description)
63
Appendix B Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomized
Controlled Trials in Journal Abstracts - Modified Checklist (25 Questions)
64
Appendix C Medline Subject Heading (MeSH) ‘Periodontal Diseases’ 66
Appendix D Bibliometrics – Journal and Abstract Metrics 68
Appendix E Abstracts Included for eligibility analysis 69
Appendix F Abstracts excluded by screening the initial 227 abstracts 86
Appendix G Abstracts for which full text articles were obtained to confirm eligibility for inclusion 87
Appendix H Abstracts and checklist questions discussed with a second reviewer 88
iv

LIST OF APPENDICES
Appendix A Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomized
Controlled Trials in Journal and Conference Abstracts - Original Checklist (17 Items with
Description)
Appendix B Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomized
Controlled Trials in Journal Abstracts - Modified Checklist (25 Questions)
Appendix C Medline Subject Heading (MeSH) ‘Periodontal Diseases’
Appendix D Bibliometrics – Journal and Abstract Metrics
Appendix E Abstracts Included for eligibility analysis
Appendix F Abstracts excluded by screening the initial 227 abstracts
Appendix G Abstracts for which full text articles were obtained to confirm eligibility for inclusion
Appendix H Abstracts and checklist questions discussed with a second reviewer

v

LIST OF TABLES
Table 1 Journal Frequency
Table 2 Journal Categories and Frequency
Table 3 Journals in Category 3 and Frequency
Table 4 Continents Frequency
Table 5 Countries Frequency
Table 6 Country Categories and Frequency
Table 7 Journal Metric Frequency
Table 8 Correlation between Journal Metrics
Table 9 Correlation between Journal Metrics [Spearman Correlation Coefficients (p value)]
Table 10 Abstract Metric – Number of Authors and Word Count
Table 11 Journals with ≥10 authors in the RCT Abstract
Table 12 Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomized
Controlled Trials in Journal Abstracts - Modified Checklist (25 Questions) Frequency
Table 13 Comparison of journal metric (5-year impact factor) with selected CONSORT for RCT
Abstracts modified checklist questions
Table 14 Comparison of journal metric (Eigenfactor
®
Score) with selected CONSORT for RCT
Abstracts modified checklist questions
Table 15 Comparison of journal metric (Article Influence
®
Score) with selected CONSORT for RCT
Abstracts modified checklist questions
Table 16 Comparison of abstract metric (word count) with selected CONSORT for RCT Abstracts
modified checklist questions
Table 17 Comparison of abstract metric (number of authors) with selected CONSORT for RCT
Abstracts modified checklist questions
Table 18 Comparison of continents with selected CONSORT for RCT Abstracts modified checklist
questions
Table 19 Comparison of journal (top four frequent) metric (5-year impact factor) with selected
CONSORT for RCT Abstracts modified checklist questions
Table 20 Comparison of journal (top four frequent) metric (Eigenfactor
®
Score) with selected
vi

CONSORT for RCT Abstracts modified checklist questions
Table 21 Comparison of journal (top four frequent)# metric (Article Influence
®
Score) with selected
CONSORT for RCT Abstracts modified checklist questions
Table 22 Comparison of abstract (top four frequent journals) metric (word count) with selected
CONSORT for RCT Abstracts modified checklist questions
Table 23 Comparison of abstract (top four frequent journals) metric (number of authors) with
selected CONSORT for RCT Abstracts modified checklist questions
Table 24 Comparison of country (top seven frequent) metric (5-year impact factor) with selected
CONSORT for RCT Abstracts modified checklist questions
Table 25 Comparison of country (top seven frequent) metric (Eigenfactor
®
Score) with selected
CONSORT for RCT Abstracts modified checklist questions
Table 26 Comparison of country (top seven frequent metric (Article Influence
®
Score) with
selected CONSORT for RCT Abstracts modified checklist questions
Table 27 Comparison of country (top seven frequent) metric (word count) with selected CONSORT
for RCT Abstracts modified checklist questions
Table 28 Comparison of country (top seven frequent) metric (number of authors) with selected
CONSORT for RCT Abstracts modified checklist questions
Table 29 Comparison of RCT Abstracts published in CONSORT endorsing journals with selected
CONSORT for RCT Abstracts modified checklist questions

vii

LIST OF FIGURES
Figure 1 Study Flow Diagram
Figure 2 Journal Categories and Frequency
Figure 3 Major countries where RCT originated (based on corresponding author’s address)
Figure 4 Countries Frequency
Figure 5 Country Categories and Frequency
Figure 6 Journal Metric (5-Year Impact Factor) Frequency
Figure 7 Journal Metric (Eigenfactor
®
Score) Frequency
Figure 8 Journal Metric (Article Influence
®
Score) Frequency
Figure 9 Correlation between Journal Metrics
Figure 10 Abstract Metric – Number of Authors
Figure 11 Abstract Metric – Word Count

viii

ABSTRACT
INTRODUCTION
Randomized controlled trials (RCT) by proper design, conduct, analysis and reporting, provide
reliable information in clinical care. Reporting of RCT abstracts is of equal importance as there is evidence
that many clinicians will change their clinical decisions based on RCT abstracts. The reporting quality of RCT
abstracts has been suboptimal. It is not clear whether the reporting quality is related to the journal metrics.
The main objective of this study is to conduct a cross-sectional survey to evaluate the reporting quality of
randomized controlled trials of periodontal diseases in journal abstracts and to perform a bibliometric
analysis. The null hypothesis was there is no association between the journal metrics (5-Year Impact Factor,
Eigenfactor
®
Score and Article Influence
®
Score), abstract metrics (Word Count, Number of authors),
journal endorsement of Consolidated Standards of Reporting Trials (CONSORT) and the overall quality of
reporting of CONSORT RCT modified checklist questions.
MATERIALS AND METHODS
CONSORT RCT Abstract Extension checklist with explanation and elaboration was utilized and
modified to assess the quality of reporting of RCT abstracts of periodontal diseases in the journal abstracts in
the year 2012. Bibliometric analysis of journal metrics (5-year impact factor, Eigenfactor
®
Score and Article
Influence
®
Score) and abstract metrics (number of authors, abstract word count), the geographic
distribution and the CONSORT endorsing journal abstracts was compared to the reporting quality of RCT
abstracts in periodontal diseases. Calibration and intra-rater agreement was done prior to the data
collection and analysis. A second reviewer was consulted for independent evaluation and clarification as
needed. For descriptive analysis, the values of continuous variables were expressed as median and
interquartile ranges and as proportion percent for binary categorical variables. For association analysis
between binary (yes/no) response variable and the continuous variable, Mann-Whitney test (for
independent samples) was used. For examining the association between 2 categorical variables, Fishers
exact test was used. Chi-square test was performed to examine the association between two sets of binary
response variables (yes/no). A p-value of <0.05 was considered statistically significant. All analyses were
conducted using SAS v9.4.
1

RESULTS
A total of 198 RCT abstracts of periodontal diseases in the year 2012 from 57 journals were included
in the study. Fifteen journals, listed as endorsers of CONSORT, contributed 108 RCT. Four journals (Journal of
periodontology, Journal of clinical periodontology, Clinical oral implants research, and European journal of
oral implantology) contributed 84/198 RCT in 2012. European countries contributed the majority (n=81,
40.91%) of RCT abstracts followed by Asia (51, 25.76%), North America (33, 16.67%), South America (23,
11.62%), Africa (7, 3.54%), and Oceania (1, 0.51%). All 7 RCT from Africa, a continent with 54 countries,
originated from one country, Egypt. Among 31 countries in this study, United States contributed the most
RCT (n=28, 14.14%) followed by India (24, 12.12%), Italy (n=22, 11.11%) and Brazil (n=20, 10.1%). The
frequency of journal metrics were 5-Year Impact Factor (Median 2.316; IQR 1.439-2.970); Eigenfactor
®
Score
(0.00474; 0.00202-0.01395); and Article Influence
®
Score (0.553; 0.382-0.755). Few RCT in periodontal diseases
were published in medical journals. A significant correlation was noted between the journal metrics among
dental journals when high impact medical journals (Antimicrobial agents and chemotherapy and PLoS
One) were excluded from correlation analyses [5-Year Impact Factor and Article Influence
®
Score: 0.93963
(p<0.0001); 5-Year Impact Factor and Eigenfactor
®
Score 0.60504 (<0.0001); Article Influence
®
Score and
Eigenfactor
®
Score 0.72699 (<0.0001)]. The number of authors in 198 RCT abstracts ranged between 2 and
20 (median n=5, IQR 4-6) while the word count ranged between 48 and 569 (median 235, IQR 205-269). All
RCT abstracts reported the experimental interventions (checklist question #5, frequency 100%). Some items
were almost always reported - participant eligibility criteria (#3, 99%); comparison interventions (#6, 99.5%);
specific objective or hypothesis (#7, 99.5%); primary outcome (#8, 99.5%); and reporting trial results as a
summary (#16, 98.5%). All RCT abstracts never reported how the allocations were concealed (#11, 0) and
the source of funding for the trials (#23, 0). Some items were almost always never reported - number of
participants included in the analysis for each intervention (#15, 2%); trial registration number (#21, 2.5%);
name of trial register (#22, 2.5%) ; and how the randomization or sequence generation was done (#22).
Dismal reporting was noted in many checklist questions including the Identification of the study as
randomized in the title (#1, 51%, design of the trial #2, 32.8%, trial setting #4, 3.5%, randomization #10, 3.5%,
blinding #12, 21.7%, details about blinding #13, 8.1%, number of participants randomized to each
intervention #14, 26.3%, effect size #17, 13.6%, precision of the estimate of the effect #18, 6.1% and adverse
effects #19, 14.1%. Strikingly, there was a very high reporting of statistical significance #25, 92.4%. European
2

countries, in particular, reported relatively better than other countries in essential questions such as #17
effect size reporting, and #18 precision (uncertainty), which have been largely unreported by rest of the
countries. Finally, despite the majority of RCT published in 2012 were by CONSORT endorsing journals, there
was no difference in the quality of reporting in majority of checklist items when compared to journals not
listed as CONSORT endorsers. With few exceptions, there was no statistically significant association between
majority of the CONSORT RCT abstract checklist questions and the journal metrics and abstract metrics
analyzed in this study. Unexpectedly, lower ranking journals in journal metrics reported certain essential
checklist questions relatively better.
CONCLUSION
The reporting quality of RCT of periodontal diseases in the journal abstracts published in 2012 needs
substantial improvement. These items have been laid out in this study to help all stakeholders – authors,
clinicians, researchers, peer reviewers, journal editors, and publishers to take note and help with the
improvement of the same. Despite few significant associations in the bibliometric factors analyzed with
better reporting, the results overall led to the failure to reject the null hypothesis that there is no association
between the journal metrics, word count and number of authors and the quality of reporting of CONSORT
RCT abstract modified checklist questions.
FUNDING
No research funding was obtained.

3

CHAPTER 1 – INTRODUCTION

Randomized controlled trials (RCT) provide the highest experimental evidence in clinical care. It
forms the basis of sound systematic reviews and meta-analyses which are considered the highest levels of
evidence to provide highest quality of clinical care. The research design includes randomization which
eliminates bias to a great degree when conducted properly preventing other sources of bias such as
allocation, attrition, performance, and assessment (Levin, 2007). In addition, the cause and effect can be
demonstrated effectively in a RCT (Cummings et al., 2013).
There is plethora of evidence that majority of clinical trials have not been conducted appropriately
due to various reasons including poor study design (Ioannidis et al., 2014; Sinha et al., 2009). Reporting of
RCT has been suboptimal as well which led to the formation of an expert group towards developing
standards in reporting. This group now well known as the CONSORT (Consolidated Standards in Reporting
Trials) comprises of experts in research methodology, epidemiologists, and journal editors among others
(CONSORT). Since 1993, several CONSORT statements and their revisions and extensions have been
published to improve the quality of reporting of RCT (Moher et al., 2010; Schulz et al., 2010). A recent
systematic review concluded that the quality of reporting RCT has remained suboptimal (Turner et al., 2012)
and dental journals have been documented to have suboptimal reporting (Pandis et al., 2010). Transparent
and clear reporting of trials has been called for consistently and all stakeholders to share responsibility for
such good quality reporting (Giannobile, 2015; Needleman et al., 2008)
Abstracts of clinical research have long been considered to be important as it conveys the
essence of a study in a short manner and authors have been urged to submit an abstract of the research
along with the full manuscript (Haynes et al., 1990; Lamson, 1931; Tenenbein, 1995). There is evidence to
show that abstracts are accessed more than the full text articles (Islamaj Dogan et al., 2009) and that
abstracts are critical as clinical decisions can be made by clinicians without referring to the full text of the
study due to various factors such as time constraints, lack of availability of full text articles, etc. (Barry et al.,
2001; Forrow et al., 1992; Johnson et al., 2013). There have been some calls in the literature to improve the
quality of reporting RCT abstracts in particular as the data contained in the abstract had deficiencies
(Pitkin and Branagan, 1998; Pitkin et al., 1999).
4

The CONSORT group recently introduced an extension to the CONSORT statement exclusively for
journal and conference abstracts (Hopewell et al., 2008a, b). This extension has been used to assess the
reporting quality of journal abstracts in many healthcare fields and the results have been suboptimal in
general while there is some evidence that adherence to CONSORT statement may improve the situation
(Berwanger et al., 2009; Faggion and Giannakopoulos, 2012; Fleming et al., 2012; Ghimire et al., 2012;
Ghimire et al., 2014; Hopewell et al., 2012; Kiriakou et al., 2014; Lempesi et al., 2014; Mbuagbaw et al., 2014;
Pandis et al., 2014; Tfelt-Hansen, 2011; Wang et al., 2010)
Periodontal disease is a broad term referring to the many diseases affecting the periodontium –
gingiva, periodontal ligament, cementum and alveolar bone. The etiology can range from accumulation
of bacterial biofilms causing plaque-induced gingivitis to autoimmune conditions such as mucus
membrane pemphigoid (Armitage, 1999). Several hundred RCT are published every year in periodontal
diseases which will have an impact in clinical care of these diseases. The quality of reporting of RCT in
dental journals in general has been suboptimal as mentioned before (Pandis et al., 2010) which will in turn
affect the interpretation of these important studies. Similarly, the reporting of RCT abstracts has been
suboptimal as well (Faggion and Giannakopoulos, 2012; Fleming et al., 2012; Kiriakou et al., 2014; Seehra et
al., 2013).
Much of the literature on assessing the quality of reporting of clinical studies has focused on high
impact journals as they tend to reach a wider audience (Can et al., 2011; Faggion and Giannakopoulos,
2012; Ghimire et al., 2012; Sinha et al., 2009). However, bibliometric trends have revealed that studies
originate in various parts of the world and they are likely to be published in lesser known journals (Geminiani
et al., 2014; Gutierrez-Vela et al., 2012). Hence, it is important to assess the quality of reporting of RCT in all
journals irrespective of their impact. There are several metrics in journals that are used to assess the quality
of the journals. The most commonly used are impact factor and 5-year impact factor which rely on the
number of citations of the article. The other two metrics are Eigenfactor
®
Score and Article Influence
®
Score
which take into consideration the impact of cited journals and also discounts journal self-citation to be fair
for new journals (Eigenfactor; JCR).
In dentistry, few studies (Faggion and Giannakopoulos, 2012; Fleming et al., 2012; Kiriakou et al.,
2014; Seehra et al., 2013) have reported on the reporting quality of RCT abstracts. Overall, the quality of
5

RCT abstract reporting has been suboptimal. However, all of them were focused on certain subgroup of
journals based on the specialty or journal metrics. Given the fact that RCT publications are increasing
exponentially in the last few years and are being published by several journals (JCR), it is imperative to
assess the quality of reporting of RCT abstracts across all journals that publish in dentistry. There is a need for
detailed documentation on the reporting quality of RCT abstracts on a wide range of Medline indexed
journals irrespective of their journal metric publishing on a specific topic in dentistry. In addition, there is a
need to understand the association between various journal metrics (5-year impact factor, Eigenfactor
score and Article Influence score) and abstract metrics such as abstract word count to the reporting
quality of RCT abstracts in periodontology. This information may help the researchers, clinicians and journal
editors and publishers to devise practical ways to improve the quality of reporting of RCT abstracts.

OBJECTIVE
To conduct a cross-sectional survey to evaluate the reporting quality of randomized controlled
trials of periodontal diseases in journal abstracts and to perform a bibliometric analysis.

SPECIFIC AIMS
1) To evaluate the reporting quality of randomized controlled trials of periodontal diseases in
journal abstracts in the year 2012 using a modified checklist questions of CONSORT RCT Abstract
Extension.
2) To compare the reporting quality of randomized controlled trials of periodontal diseases in
journal abstracts and the
a) journal metrics as defined by the 5-year impact factor score, Eigenfactor
®
Score and
Article Influence
®
Score;
b) number of words in the abstract;
c) number of authors; and
6

d) geographic region (countries and their respective continents) of corresponding author;
3) To conduct subgroup analyses as described above in 1 & 2 restricted to frequent journals and
countries which publish the most number of RCT.
4) To compare the reporting quality of randomized controlled trials of periodontal diseases in
journal abstracts between CONSORT endorsing journals and those who do not endorse CONSORT
per CONSORT published list of journals in May 2015.

NULL HYPOTHESIS
There is no association between the journal metrics (5-Year Impact Factor, Eigenfactor
®
Score and
Article Influence
®
Score), abstract metrics (Word Count, Number of authors), journal endorsement
of Consolidated Standards of Reporting Trials (CONSORT) and the overall quality of reporting of
CONSORT RCT modified checklist questions.

7

CHAPTER 2 – MATERIALS AND METHODS

DEVELOPMENT OF CONSORT RCT ABSTRACT MODIFIED CHECKLIST QUESTIONS
The original Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomized
Controlled Trials in Journal and Conference Abstracts has 17 Items with description (Hopewell et al., 2008a).
This checklist is meant to be used for both journal and conference abstracts. A couple of items are required
mainly for conference abstracts (author information and trial status). The rest of the 15 items are considered
essential for any RCT abstract (Appendix A).
The CONSORT authors have recommended that this checklist be used with the explanation and
elaboration document to extract the details that are necessary for optimal reporting (Hopewell et al.,
2008b). Many authors who have used this checklist have modified this checklist to aid in their assessment
and also to get multiple information that may be embedded within one checklist item (Chen et al., 2010;
Wang et al., 2010). It is very useful to obtain information on effect size which is only one of the criteria in
evaluation of outcomes in results section of abstract, the other two being primary results and measure of
the precision (confidence interval). Also, many authors focus on the presentation of ‘p’ value but more
often do not present the effect size (Addy and Newcombe, 2005; Pocock et al., 1987; Sullivan and Feinn,
2012). Though the abstracts in general today follow a structured format, it is still common to see
occasionally unstructured abstracts. Structured abstracts have been shown to improve understanding of
the studies better (Scherer and Crawley, 1998; Sharma and Harrison, 2006).
With the goal of being able to use the CONSORT RCT Abstract checklist effectively, a simple,
modified checklist with focused 25 questions was prepared with the statements in the CONSORT RCT
Explanation document as the template for the questions (Hopewell et al., 2008b) (Appendix B).
RCT ABSTRACT SEARCH PROCESS
National Library of Medicine (NLM) database PubMed was searched to retrieve all the RCT
published under the Medline Subject Heading (MeSH) term ‘Periodontal Diseases’ (Appendix C). Filters
applied were Languages: English, Species: Humans; Article Types: Randomized Controlled Trial; and
8

Publication Dates – Custom Range: 2012/01/01-2012/12/31. The goal behind this specific search was to
focus on search reproducibility rather than to capture as many RCT as possible through multiple databases
and using unrestricted search terms. A similar search was also conducted with the filter of Publication Dates
– Custom Range: 2011/01/01-2011/12/31 to retrieve RCT from 2011. The journal and abstract metrics
collected from these RCT abstracts are listed with explanations and sources in Appendix D.
CALIBRATION PHASE – 2011 RCT ABSTRACTS
All the RCT citations and abstracts were retrieved for the year 2011 and were imported to
EndNote
®
X6 software (Thomson Reuters, Philadelphia, USA). The citations were sorted in the software to
ensure only the 2011 citations were included (n=193). For instance, 2012 RCT citations were included in the
search that were published online early in 2011. A randomization online website (www.randomizer.org) was
used to randomly produce 10 numbers between 1 and 193. The corresponding randomly chosen RCT
abstracts were then evaluated with the CONSORT RCT modified checklist questions twice at two different
time points (23 questions based on the original CONSORT RCT Abstract checklist were tested for calibration;
questions 24 and 25 were not part of the original checklist and hence not included). The intra-rater
assessment was calculated using Cohen kappa κ statistics. Excellent agreement was considered when
κ≥0.75, fair when κ=0.40-0.74 and poor when κ≤0.39.
2012 RCT ABSTRACT DATA COLLECTION PHASE
All the RCT citations and abstracts retrieved for the year 2012 were imported to EndNote
®
X6
software (Thomson Reuters, Philadelphia, USA) as above. The citations were sorted in the software to ensure
only the 2012 citations and abstracts were included. For instance, 2013 RCT citations that were included in
the search (published online early in 2012) was discarded.
INCLUSION CRITERIA
The inclusion criteria included only RCT abstracts in humans published in English in the year 2012
under the MeSH term ‘Periodontal Diseases’ with clearly defined periodontal interventions and outcomes.

9

EXCLUSION CRITERIA
The exclusion criteria included RCT with no periodontal outcomes mentioned such as studies done
in Endodontics, Prosthodontics, third molar surgery, and radicular cyst enucleation. Studies that are not RCT
such as observational study, animal studies, in vitro studies, ex vivo studies, and secondary research such as
cost effectiveness study based on RCT were also excluded. Gray literature, theses, dissertations,
conference abstracts were not included. When in doubt, full text articles were obtained to read the
Materials and Methods section only to confirm eligibility.
EVALUATION USING CONSORT RCT ABSTRACT MODIFIED CHECKLIST QUESTIONS
The final eligible abstracts were evaluated using the CONSORT RCT Abstracts - Modified Checklist
(25 Questions). Bibliometric information was gathered simultaneously from Journal Citation Reports
®

database during the evaluation and entered into a MS Excel
®
data spreadsheet.
SECOND REVIEWER
A periodontology senior graduate resident (HM) familiar with the CONSORT RCT Abstract checklist
evaluation was consulted as a second reviewer for selected checklist questions for a second independent
evaluation and assessment.
STATISTICAL ANALYSIS
For descriptive analysis the values of continuous variables were expressed as median and
interquartile ranges and as proportion percent for binary categorical variables. For association analysis
between binary (yes/no) response variable and the continuous variable, Mann-Whitney test (for
independent samples) was used. For examining the association, the association between 2 categorical
variables, Fishers exact test was used. Chi-square test was performed to examine the association between
two sets of binary response variables (yes/no). A p-value of <0.05 was considered statistically significant. All
analyses were conducted using SAS v9.4.

10

CHAPTER 3 – RESULTS

CALIBRATION PHASE – 2011 RCT ABSTRACTS
The modified checklist questions with details aided in easy assessment of the RCT Abstract with a
kappa mean score of 0.93 ± 0.08 (95% C.I. 0.049) indicating high intra-rater agreement during calibration
phase.
2012 RCT ABSTRACT DATA COLLECTION PHASE
The study flow diagram (Figure 1) illustrates clearly the search process and the excluded abstracts.
The initial search yielded a total of 300 citations of which 227 abstracts were included for abstract eligibility
analysis (Appendix E). A total of 198 abstracts were considered eligible for final analysis using the RCT
Abstract modified checklist questions. The rationale for exclusion is detailed in Appendix F & G.
SECOND REVIEWER
The second reviewer was consulted for 23 abstracts for further independent evaluation. The
second reviewer were in agreement for majority (>90%) of the responses of the first evaluation by the
primary author (SK). The rare conflicts were solved with simple discussion and the consensus was taken for
final evaluation (Appendix H).
11

Figure 1 - Study Flow Diagram
* Refer to Appendix F & G - Excluded abstracts for detailed explanation

198 abstracts included for CONSORT RCT Abstracts Modified
Checklist Survey and Bibliometric Analysis
204 abstracts; 29 full text articles from the 204 abstracts were
retrieved to check for eligibility as an RCT study
PubMed Database
http://www.ncbi.nlm.nih.gov/pubmed
Medline Subject Heading –
‘Periodontal Diseases’

Filters:
Languages: English
Species: Humans
Article Types: Randomized Controlled Trial
Publication Dates – Custom Range: 2012/01/01-2012/12/31
Search Output: 300 citations
Imported 300 citations to reference software EndNote
®
6
Citations organized by year in EndNote
®
6
73 citations are 2013 publications but were published online
early in 2012 and hence excluded
Abstracts of 227 citations retrieved and read for eligibility
23 Abstracts
excluded *
6 Abstracts
excluded *
73 citations
excluded*
12

JOURNAL FREQUENCY
Fifty seven journals published 198 RCTs involving periodontal diseases in 2012. About half (49.49%) of
the RCT published in 2012 were from a total of six journals (Journal of periodontology, Journal of clinical
periodontology, Clinical oral implants research, European journal of oral implantology, American journal of
dentistry, and Clinical implant dentistry and related research) while the remaining 50% were contributed in
51 journals (Table 1). This underscores the importance of evaluating reporting quality in all journals and not
only the major journals in Periodontology. About one-third (30.81%) of the trials were published in Journal of
Periodontology (flagship publication of the American Academy of Periodontology) and Journal of clinical
periodontology (flagship publication of the European Academy of Periodontology).
Table 1 - Journal Frequency
Journal Title Journal Abbreviation CONSORT
Endorsement
*

(Yes/No)
Freque
ncy
Perce
nt
Cumulati
ve
Frequen
cy
Cumulati
ve
Percent
Journal of
periodontology
J Periodontol Yes 31 15.66 31 15.66
Journal of clinical
periodontology
J Clin Periodontol Yes 30 15.15 61 30.81
Clinical oral
implants research
Clin Oral Implants Res Yes 12 6.06 73 36.87
European journal
of oral
implantology
Eur J Oral Implantol No 11 5.56 84 42.42
American journal
of dentistry
Am J Dent Yes 8 4.04 92 46.46
Clinical implant
dentistry and
related research
Clin Implant Dent Relat
Res
No 6 3.03 98 49.49
The Journal of
clinical dentistry
J Clin Dent No 6 3.03 104 52.53
Photomedicine
and laser surgery
Photomed Laser Surg No 6 3.03 110 55.56
Clinical oral
investigations
Clin Oral Investig Yes 5 2.53 115 58.08
The International
journal of oral &
maxillofacial
implants
Int J Oral Maxillofac
Implants
No 5 2.53 120 60.61
Lasers in medical
science
Lasers Med Sci No 5 2.53 125 63.13
Quintessence
international
Quintessence Int Yes 5 2.53 130 65.66
International
journal of dental
hygiene
Int J Dent Hyg No 4 2.02 134 67.68
13

Table 1 - Journal Frequency
Journal Title Journal Abbreviation CONSORT
Endorsement
*

(Yes/No)
Freque
ncy
Perce
nt
Cumulati
ve
Frequen
cy
Cumulati
ve
Percent
The International
journal of
periodontics &
restorative dentistry
Int J Periodontics
Restorative Dent
No 4 2.02 138 69.7
Journal of oral and
maxillofacial
surgery
J Oral Maxillofac Surg Yes 4 2.02 142 71.72
Compendium of
continuing
education in
dentistry
Compend Contin Educ
Dent
No 3 1.52 145 73.23
Implant dentistry Implant Dent No 3 1.52 148 74.75
Journal of the
International
Academy of
Periodontology
J Int Acad Periodontol No 3 1.52 151 76.26
Journal of
periodontal
research
J Periodontal Res Yes 3 1.52 154 77.78
Australian dental
journal
Aust Dent J Yes 2 1.01 156 78.79
Indian journal of
dental research
Indian J Dent Res No 2 1.01 158 79.8
Journal of dental
research
J Dent Res Yes 2 1.01 160 80.81
Journal of
investigative and
clinical dentistry
J Investig Clin Dent No 2 1.01 162 81.82
PLoS one PLoS One Yes 2 1.01 164 82.83
Swedish dental
journal
Swed Dent J No 2 1.01 166 83.84
Acta cytologica Acta Cytol No 1 0.51 167 84.34
Acta odontológica
latinoamericana
Acta Odontol Latinoam No 1 0.51 168 84.85
American journal
of perinatology
Am J Perinatol No 1 0.51 169 85.35
Antimicrobial
agents and
chemotherapy
Antimicrob Agents
Chemother
No 1 0.51 170 85.86
Brazilian dental
journal
Braz Dent J No 1 0.51 171 86.36
Brazilian oral
research
Braz Oral Res No 1 0.51 172 86.87
The British journal of
oral & maxillofacial
surgery
Br J Oral Maxillofac Surg Yes 1 0.51 173 87.37
The Chinese
journal of dental
research
Chin J Dent Res No 1 0.51 174 87.88
14

Table 1 - Journal Frequency
Journal Title Journal Abbreviation CONSORT
Endorsement
*

(Yes/No)
Freque
ncy
Perce
nt
Cumulati
ve
Frequen
cy
Cumulati
ve
Percent
European journal
of clinical
microbiology &
infectious diseases
Eur J Clin Microbiol Infect
Dis
No 1 0.51 175 88.38
European journal
of paediatric
dentistry
Eur J Paediatr Dent No 1 0.51 176 88.89
General dentistry Gen Dent No 1 0.51 177 89.39
Gerodontology Gerodontology No 1 0.51 178 89.9
Health psychology Health Psychol Yes 1 0.51 179 90.4
International
dental journal
Int Dent J No 1 0.51 180 90.91
Journal of
biomedical
materials research.
Part B, Applied
biomaterials
J Biomed Mater Res B
Appl Biomater
No 1 0.51 181 91.41
Journal of breath
research
J Breath Res No 1 0.51 182 91.92
Journal of the
California Dental
Association
J Calif Dent Assoc No 1 0.51 183 92.42
The journal of
contemporary
dental practice
J Contemp Dent Pract No 1 0.51 184 92.93
Journal of dentistry J Dent Yes 1 0.51 185 93.43
Journal of dental
hygiene
J Dent Hyg No 1 0.51 186 93.94
Journal of the
Indian Society of
Pedodontics and
Preventive
Dentistry
J Indian Soc Pedod Prev
Dent
Yes 1 0.51 187 94.44
The Journal of oral
implantology
J Oral Implantol No 1 0.51 188 94.95
Journal of oral
rehabilitation
J Oral Rehabil No 1 0.51 189 95.45
Kathmandu
University medical
journal
Kathmandu Univ Med J No 1 0.51 190 95.96
Lasers in surgery
and medicine
Lasers Surg Med No 1 0.51 191 96.46
Medicina oral,
patología oral y
cirugía bucal
Med Oral Patol Oral Cir
Bucal
No 1 0.51 192 96.97
Minerva
stomatologica
Minerva Stomatol No 1 0.51 193 97.47
Oral diseases Oral Dis No 1 0.51 194 97.98
Oral health and
dental
management
Oral Health Dent Manag No 1 0.51 195 98.48
15

Table 1 - Journal Frequency
Journal Title Journal Abbreviation CONSORT
Endorsement
*

(Yes/No)
Freque
ncy
Perce
nt
Cumulati
ve
Frequen
cy
Cumulati
ve
Percent
Oral health &
preventive
dentistry
Oral Health Prev Dent No 1 0.51 196 98.99
Oral surgery, oral
medicine, oral
pathology and oral
radiology
Oral Surg Oral Med Oral
Pathol Oral Radiol
No 1 0.51 197 99.49
The Southeast
Asian journal of
tropical medicine
and public health
Southeast Asian J Trop
Med Public Health
No 1 0.51 198 100

* Information about CONSORT Endorsement by the journals was obtained from the CONSORT website only
which lists all the 585 journals currently endorsing CONSORT guidelines. Accessed on May 20, 015. Fifteen
journals in this study contributing a total of 108 RCTs are listed in CONSORT website as CONSORT Endorsers.
http://www.consort-statement.org/about-consort/endorsers

16

JOURNAL CATEGORIES AND FREQUENCY
Journals were divided into three categories to study the distribution better (Table 2). Only 4 journals
contributed ten or more RCTs in 2012 (Table 3, Figure 2) - Journal of periodontology, Journal of clinical
periodontology, Clinical oral implants research, and European journal of oral implantology. Altogether,
these 4 journals contributed 84 RCT out of 198 included in this study.

Figure 2 - Journal Categories and Frequency

Frequency

Journal Categories

Table 2 - Journal Categories and Frequency
Categories Frequency Percent Cumulative Frequency Cumulative Percent
Category 1 Journals with 1 RCT 32 56.14 32 56.14
Category 2 Journals with 2-10 RCT 21 36.84 53 92.98
Category 3 Journals with ≥10 RCT 4 7.02 57 100.0
17

Table 3 - Journals in Category 3 and Frequency
Journal Title Journal Abbreviation Count (≥ 10) Percent
Journal of periodontology J Periodontol 31 15.66
Journal of clinical periodontology J Clin Periodontol 30 15.15
Clinical oral implants research Clin Oral Implant Res 12 6.06
European journal of oral implantology Eur J Oral Implantol 11 5.56

CONTINENTS FREQUENCY
Majority of RCT were published by authors (corresponding author) in Europe with the least reported
from Africa and Oceania. It is striking to note the paucity of RCT from Africa given that Africa has a total of
54 countries (Table 4).

COUNTRIES FREQUENCY
United States tops the list with 24 RCT published in this sample followed by India, Italy, Brazil and
Turkey. It is interesting to note the increasing body of RCT literature arising from Asia and South America in
the topic of periodontal diseases (Table 5, Figures 3 & 4).
Table 4 - Continents Frequency
Continent Frequency Percent Cumulative Frequency Cumulative Percent
Country not reported, unknown 2 1.01 2 1.01
Africa 7 3.54 9 4.55
Asia 51 25.76 60 30.30
Europe 81 40.91 141 71.21
North America 33 16.67 174 87.88
Oceania 1 0.51 175 88.38
South America 23 11.62 198 100.0
18

Table 5 - Countries Frequency
Country Frequency Percent Cumulative Frequency Cumulative Percent
USA 28 14.14 28 14.14
India 24 12.12 52 26.26
Italy 22 11.11 74 37.37
Brazil 20 10.1 94 47.47
Turkey 13 6.57 107 54.04
Germany 11 5.56 118 59.6
Sweden 11 5.56 129 65.15
Egypt 7 3.54 136 68.69
Canada 5 2.53 141 71.21
Spain 5 2.53 146 73.74
The Netherlands 5 2.53 151 76.26
Iran 4 2.02 155 78.28
Switzerland 4 2.02 159 80.3
Belgium 3 1.52 162 81.82
Norway 3 1.52 165 83.33
Poland 3 1.52 168 84.85
Not Reported 2 1.01 170 85.86
Argentina 2 1.01 172 86.87
Denmark 2 1.01 174 87.88
Greece 2 1.01 176 88.89
Hungary 2 1.01 178 89.9
Israel 2 1.01 180 90.91
Japan 2 1.01 182 91.92
UK 2 1.01 184 92.93
Austria 1 0.51 185 93.43
Chile 1 0.51 186 93.94
China 1 0.51 187 94.44
France 1 0.51 188 94.95
Ireland 1 0.51 189 95.45
Korea 1 0.51 190 95.96
Macedonia 1 0.51 191 96.46
New Zealand 1 0.51 192 96.97
Pakistan 1 0.51 193 97.47
Republic of Serbia 1 0.51 194 97.98
Saudi Arabia 1 0.51 195 98.48
Serbia 1 0.51 196 98.99
Taiwan 1 0.51 197 99.49
Thailand 1 0.51 198 100
19

Figure 3 – Major countries where RCT originated (based on corresponding author’s address, highlited in blue
outline). Note the paucity of studies from African nations.

Figure 4 - Countries Frequency

Frequency

Country

20

COUNTRY CATEGORIES AND FREQUENCY
Countries were divided into three categories to study the distribution better (Table 6). A total of 7
countries contributed ten or more RCTs in 2012 (Table 6, Figure 5) - USA, India, Italy, Brazil, Turkey, Germany,
and Sweden. Altogether, these 7 countries contributed 129 RCT out of 198 included in this study. The
remaining RCT were published by 14 countries (1 RCT each) and 17 countries (2-10 RCT).

Figure 5 - Country Categories and Frequency

Frequency

Country Categories

Table 6 - Country Categories and Frequency

Categories Frequency Percent Cumulative
Frequency
Cumulative
Percent
Category 1 Countries with 1 RCT
publications
14 36.84 14 36.84
Category 2 Countries with 2-10 RCT
publications
17 44.74 31 81.58
Category 3 Countries with >10 RCT
publications
7 18.42 38 100.0
21

JOURNAL METRIC FREQUENCY
RCT in periodontal diseases were published in journals with a wide impact metric. Some studies were
published in medical journals that had higher impact than the top ranking dental journals (Table 7, Figures
6, 7 & 8).

Table 7 - Journal Metric Frequency
Journal Metric Number of journals Median Minimum Maximum Interquartile range (IQR)
5-Year Impact Factor 37 2.316 0.575 5.224 1.439-2.970
Eigenfactor
®
Score 41 0.00474 0.00061 1.16582 0.00202-0.01395
Article Influence
®
Score 37 0.553 0.160 1.896 0.382-0.755

Figure 6 - Journal Metric (5-Year Impact Factor) Frequency
Journal Metric Number of abstracts Median Minimum Maximum Interquartile range (IQR)
5-Year Impact Factor 37 2.316 0.575 5.224 1.439-2.970

5-Year Impact Factor
22

Figure 7 - Journal Metric (Eigenfactor
®
Score) Frequency
Journal Metric Number of abstracts Median Minimum Maximum Interquartile range (IQR)
Eigenfactor
®
Score 41 0.00474 0.00061 1.16582 0.00202-0.01395

Eigenfactor
®
Score
Figure 8 - Journal Metric (Article Influence
®
Score) Frequency
Journal Metric Number of abstracts Median Minimum Maximum Interquartile range (IQR)
Article Influence
®
Score 37 0.553 0.160 1.896 0.382-0.755

Article Influence
®
Score
23

CORRELATION BETWEEN JOURNAL METRICS
When the journal metrics were correlated removing the outliers of high impact medical journals, a very high
correlation was noted between 5-Year Impact Factor and Article Influence
®
Score. The other metrics had a
reasonably good correlation as well.

*
Medical journals Antimicrobial agents and chemotherapy (Antimicrob Agents Chemother) and PLoS One
were removed from final correlation analyses as outliers in Eigenfactor
®
scores (values >0.06 cut-off; 1.16582
and 0.09405 respectively)
Table 9 - Correlation between Journal Metrics [Spearman Correlation Coefficients (p value)]
Journal Metric (n=35) Article Influence
®
Score Eigenfactor
®
Score
5-Year Impact Factor 0.93963 (<0.0001) 0.60504 (<0.0001)
Article Influence
®
Score - 0.72699 (<0.0001)
Figure 9 - Correlation between Journal Metrics

Table 8 - Correlation between Journal Metrics
Journal Metric Number of abstracts
*
Median Minimum Maximum
5-Year Impact Factor 35 2.239 0.575 5.224
Eigenfactor
®
Score 35 0.00505 0.00061 0.02239
Article Influence
®
Score 35 0.553 0.160 1.896
24

ABSTRACT METRIC – NUMBER OF AUTHORS AND WORD COUNT
The majority of RCT were published by 4-6 authors with some studies being reported by as few as 2 authors
and some as high as 20 authors (Table 10, Figures 10 & 11). Eight RCT had ≥ 10 authors (Table 11) published
in Journal of dental research, European journal of oral implantology, Journal of clinical periodontology,
Antimicrobial agents and chemotherapy, Clinical oral investigations.
The majority of abstracts had a word count of 205-269 with one abstract as low as 48 words and some as
high as 569.

Table 10 - Abstract Metric – Number of Authors and Word Count
Abstract Metric Number of abstracts Median Minimum Maximum Interquartile range (IQR)
Number of authors 198 5 2 20 4-6
Word Count 198 235 48 569 205-269

Figure 10 - Abstract Metric – Number of Authors
Abstract Metric Number of abstracts Median Minimum Maximum Interquartile range (IQR)
Number of authors 198 5 2 20 4-6

Number of authors
25

JOURNALS WITH ≥10 AUTHORS IN THE RCT ABSTRACT
Table 11 – Journals with ≥10 authors in the RCT Abstract
Journal Title Journal Abbreviation Number of Authors (≥ 10)
Journal of dental research J Dent Res 20
European journal of oral implantology Eur J Oral Implantol 12
Journal of clinical periodontology J Clin Periodontol 11
Journal of dental research J Dent Res 11
Antimicrobial agents and chemotherapy Antimicrob Agents Chemother 10
Clinical oral investigations Clin Oral Investig 10
Journal of clinical periodontology J Clin Periodontol 10
Journal of clinical periodontology J Clin Periodontol 10

Figure 11 - Abstract Metric – Word Count
Abstract Metric Number of abstracts Median Minimum Maximum Interquartile range (IQR)
Word Count 198 235 48 569 205-269

Word count
26

CONSORT RCT IN JOURNAL ABSTRACTS - MODIFIED CHECKLIST (25 QUESTIONS) FREQUENCY
Table12 summarizes the main results of the 198 RCT abstracts evaluated on the CONSORT RCT
Abstract modified checklist questions. All RCT abstracts reported the experimental interventions (checklist
question #5, frequency 100%). Some items were almost always reported - participant eligibility criteria (#3,
99%); comparison interventions (#6, 99.5%); specific objective or hypothesis (#7, 99.5%); primary outcome
(#8, 99.5%); and reporting trial results as a summary (#16, 98.5%). All RCT abstracts never reported how the
allocations were concealed (#11, 0) and the source of funding for the trials (#23, 0). Some items were
almost always never reported - number of participants included in the analysis for each intervention (#15,
2%); trial registration number (#21, 2.5%); name of trial register (#22, 2.5%) ; and how the randomization or
sequence generation was done (#22). Dismal reporting was noted in many checklist questions including
the identification of the study as randomized in the title (#1, 51%), design of the trial (#2, 32.8%), trial setting
(#4, 3.5%), randomization (#10, 3.5%), blinding (#12, 21.7%), details about blinding (#13, 8.1%), number of
participants randomized to each intervention (#14, 26.3%), effect size (#17, 13.6%), precision of the
estimate of the effect (#18, 6.1%) and adverse effects (#19, 14.1%). Strikingly, there was a very high
reporting of statistical significance (#25, 92.4%).
Though not part of the essential checklist item in CONSORT, it was interesting to note that 92.4% of
RCT abstracts reported ‘statistical significance’ but only 13.6% and 6.1% reported on the effect size, and
precision of the estimate of the effect respectively.
Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and
≥189 out of 198 abstracts surveyed were excluded from all comparisons with journal and abstract metrics.
There was discrepancy between the remaining 13 checklist questions (#1, 2, 4, 9, 12, 13, 14, 17, 18, 19, 20,
24, and 25) and were subjected to further analyses with the corresponding bibliometric data. In addition,
journal subset and country subset analyses were performed to check if these factors had any association
with reporting quality of RCT abstracts.

27

Table 12 – Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomized Controlled Trials in Journal Abstracts - Modified Checklist
(25 Questions) Frequency
Item
**
Description Q# In the RCT abstract being assessed, did the authors Yes Percent
Title Identification of the study
as randomized
1. state explicitly in the title that the participants were randomly
assigned to their comparison groups?
101 51.0
Trial Design Description of the trial
design (e.g. parallel,
cluster, non-inferiority)
2. describe the design of the trial (e.g., parallel group, cluster
randomized, crossover, factorial, superiority, equivalence or
noninferiority, or some other combination of these designs)?
Note: Select ‘yes’ if split-mouth design is mentioned.
65 32.8
Methods Participants Eligibility criteria for
participants and the
settings where the data
were collected
3. describe the participant eligibility criteria that may relate to
demographics, clinical diagnosis, and comorbid conditions?
196 99.0
4. provide a clear description of the trial setting in which they were
studied, so that readers may assess the external validity
(generalizability) of the trial and determine its applicability to their
own setting?
Note: Please note that this is the location(s) of the trial such as the
University or private clinic, not where the participants come from.
7 3.5
Interventions Interventions intended for
each group
5. describe the essential features of the experimental interventions? 198 100.0
6. describe the essential features of comparison interventions? 197 99.5
Objective Specific objective or
hypothesis
7. provide a clear statement of the specific objective or hypothesis
addressed in the trial?
197 99.5
Outcome Clearly defined primary
outcome for this report
8. explicitly state the primary outcome for the trial? 197 99.5
9. explicitly state when the primary outcome was assessed (e.g., the
time frame over which it was measured)?
188 94.9
Randomization How participants were
allocated to interventions
10. report how the randomization or sequence generation was done
(e.g., use of computer or random number table)?
3 1.5
11. describe how the allocations were concealed (e.g., sequentially
numbered, opaque sealed envelopes)?
0 ----
Blinding
(Masking)
Whether or not
participants, care givers,
and those assessing the
outcomes were blinded
to group assignment
12. report about blinding?
Note: Select 'yes' if the authors mention about blinding with less well-
understood terms such as ‘single’ or ‘double’ blind that CONSORT
recommends that authors should avoid.
43 21.7
13. describe whether or not participants, those administering the
intervention (usually health-care providers), and those assessing the
outcome (the data collectors and analysts) were blinded to the
group allocation?
16 8.1
Results Numbers
Randomized
Number of participants
randomized to each
group
14. report the number of participants randomized to each intervention?
Note: Overall randomized number of participants is not adequate.
The number of participants randomized to each intervention should
be provided.
52 26.3
28

Table 12 – Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomized Controlled Trials in Journal Abstracts - Modified Checklist
(25 Questions) Frequency
Item
**
Description Q# In the RCT abstract being assessed, did the authors Yes Percent
Numbers
Analyzed
Number of participants
analyzed in each group
15. report the number of participants included in the analysis for each
intervention?
Note: Overall analyzed number of participants is not adequate. The
number of participants analyzed in each intervention should be
provided.
4 2.0
Outcome For the primary outcome,
a result for each group
and the estimated effect
size and its precision
16. for the primary outcome, report trial results as a summary of the
outcome in each group (e.g., the number of participants with or
without the event, or the mean and standard deviation of
measurements)?
195 98.5
17. for the primary outcome, report the contrast between groups known
as the effect size? For binary outcomes, the effect size could be the
relative risk, relative risk reduction, odds ratio, or risk difference. For
survival time data, the measurement could be the hazard ratio or
difference in median survival time. For continuous data, the effect
measure is usually the difference in means.
27 13.6
18. for the primary outcome, present the confidence intervals for the
contrast between groups and as a measure of the precision
(uncertainty) of the estimate of the effect?
12 6.1
Harms Important adverse
events or side effects
19. describe any important adverse (or unexpected) effects of an
intervention in the abstract? If no important adverse events have
occurred, did the authors state this explicitly?
28 14.1
Conclusions General interpretation of
the results
20. clearly state the conclusions of the trial, consistent with the results
reported in the abstract, along with their clinical application
(avoiding over-generalization) balancing the benefits and harms in
their conclusions. ? Where applicable, authors should also note
whether additional studies are required before the results are used in
clinical settings.
183 92.4
Trial Registration Registration number and
name of trial register
21. provide details of the trial registration number? 5 2.5
22. provide details of the name of trial register? 5 2.5
Funding Source of funding 23. report the source of funding for the trial? 0 ----
Additional useful data Structured abstract
***
24. reports the abstract in traditional structure with subtitles
(Introduction/background, materials/methods, results, conclusion)
165 83.3
Statistical significance 25. report 'statistical' significance with or without a ‘p’ value 183 92.4

29

COMPARISON OF JOURNAL METRIC (5-YEAR IMPACT FACTOR) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED CHECKLIST QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked 5-year impact factor scores in
the categories of: reporting of randomization in the title, number of participants randomized to each intervention, conclusions and structured
abstract.
Table 13 - Comparison of journal metric (5-year impact factor) with selected CONSORT for RCT Abstracts* modified checklist questions
Q# Key words of the checklist questions Yes 5-year impact factor
**
No 5-year impact factor p-value
***

n Median (IQR) n Median (IQR)
1. title - participants randomly assigned 93 3.083 (2.694-4.506) 71 2.557 (1.548-3.083) <0.0001
2. design of the trial 51 2.694 (1.684-4.206) 113 3.083 (2.316-4.206) 0.1110
4. trial setting 4 2.189 (1.4745-3.959) 160 3.083 (1.833-4.206) 0.5840
9. when the primary outcome was assessed 159 3.083 (1.833-4.206) 5 3.083 (1.684-3.083) 0.6788
12. report about blinding 32 3.027 (1.504-4.470) 132 3.083 (2.401-4.206) 0.3757
13. details about blinding 13 1.504 (1.504-4.506) 151 3.083 (2.239-4.206) 0.2344
14. number of participants randomized to each intervention 45 3.083 (2.557-4.206) 119 3.083 (1.714-4.206) 0.6454
17. effect size 24 4.206 (2.694-4.506) 140 3.083 (1.714-3.864) 0.0119
18. confidence intervals-precision (uncertainty) 12 2.885 (2.694-4.506) 152 3.083 (1.714-4.206) 0.1208
19. adverse (or unexpected) effects 24 2.694 (1.572-3.713) 140 3.083 (1.833-4.206) 0.2983
20. conclusions 154 3.083 (2.316-4.206) 10 1.504 (1.504-1.714) 0.0002
24. structured abstract 139 3.083 (1.833-4.206) 25 2.597 (1.714-2.602) 0.0171
25. statistical significance 155 3.083 (1.833-4.206) 9 3.083 (1.548-4.206) 0.8729

* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** 5-year impact factor maintained at 3 decimals as reported in Journal of Citation Reports®.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.

30

COMPARISON OF JOURNAL METRIC (EIGENFACTOR
®
SCORE) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED CHECKLIST QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked Eigenfactor
®
scores in the
categories of: design of the trial, details about blinding, conclusions. Note that the journals with low rank Eigenfactor
®
scores reported trial design
and details about blinding better.
Table 14 - Comparison of journal metric (Eigenfactor® Score) with selected CONSORT for RCT Abstracts* modified checklist questions
Q# Key words of the checklist questions Yes Eigenfactor
®
Score
**
No Eigenfactor
®
Score p-
value
***
n Median (IQR) n Median (IQR)
1. title - participants randomly assigned 95 0.01478 (0.00323-0.01492) 76 0.00490 (0.00256-0.01492) 0.1498
2. design of the trial 56 0.00547 (0.00239-0.01478) 115 0.01478 (0.00369-0.01492) 0.0035
4. trial setting 5 0.00178 (0.00130-0.01538) 166 0.01437 (0.00270-0.01492) 0.5611
9. when the primary outcome was assessed 166 0.00858 (0.00270-0.01492) 5 0.01492 (0.01478-0.01492) 0.1887
12. report about blinding 34 0.01076 (0.00241-0.01492) 137 0.01395 (0.00369-0.01492) 0.6403
13. details about blinding 15 0.00241 (0.00236-0.01478) 156 0.01478 (0.00369-0.01492) 0.0184
14. number of participants randomized to each intervention 48 0.01437 (0.00320-0.01492) 123 0.00930 (0.00270-0.01492) 0.8968
17. effect size 24 0.01478 (0.00186-0.01478) 147 0.00785 (0.00310-0.01492) 0.4362
18. confidence intervals-precision (uncertainty) 12 0.00804 (0.00130-0.01478) 159 0.01395 (0.00310-0.01492) 0.1193
19. adverse (or unexpected) effects 24 0.00372 (0.00154-0.01478) 147 0.01478 (0.00369-0.01492) 0.0462
20. conclusions 160 0.01478 (0.00346-0.01492) 11 0.00241 (0.00241-0.00586) 0.0308
24. structured abstract 143 0.01478 (0.00323-0.01492) 28 0.00586 (0.00236-0.00633) 0.0732
25. statistical significance 161 0.01395 (0.00310-0.01492) 10 0.00874 (0.00236-0.01536) 0.9736

* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Eigenfactor
®
score maintained at 5 decimals as reported in Journal of Citation Reports®.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.

31

COMPARISON OF JOURNAL METRIC (ARTICLE INFLUENCE® SCORE) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED CHECKLIST QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked Article Influence
®
Score in the
categories of: reporting randomization in the title, trial design, effect size and conclusions. Note that the low ranks of Article Influence
®
Score
reported trial design better.
Table 15 - Comparison of journal metric (Article Influence
®
Score) with selected CONSORT for RCT Abstracts* modified checklist questions
Q# Key words of the checklist questions Yes Article Influence
®
Score
**
No Article Influence
®
Score p-
value
***
n Median (IQR) n Median (IQR)
1. title - participants randomly assigned 93 0.802 (0.631-1.184) 71 0.606 (0.407-0.802) <0.0001
2. design of the trial 51 0.631 (0.407-1.016) 113 0.802 (0.553-1.047) 0.0418
4. trial setting 4 0.556 (0.435-1.264) 160 0.802 (0.523-1.047) 0.6139
9. when the primary outcome was assessed 159 0.802 (0.523-1.047) 5 0.802 (0.481-0.802) 0.7144
12. report about blinding 32 0.779 (0.407-1.184) 132 0.802 (0.578-1.016) 0.6976
13. details about blinding 13 0.407 (0.407-1.184) 151 0.802 (0.553-1.016) 0.4771
14. number of participants randomized to each intervention 45 0.802 (0.631-1.016) 119 0.802 (0.481-1.047) 0.6574
17. effect size 24 1.016 (0.631-1.184) 140 0.802 (0.481-1.016) 0.0379
18. confidence intervals-precision (uncertainty) 12 0.717 (0.631-1.184) 152 0.802 (0.481-1.032) 0.3665
19. adverse (or unexpected) effects 24 0.631 (0.456-1.016) 140 0.802 (0.523-1.047) 0.3093
20. conclusions 154 0.802 (0.553-1.047) 10 0.407 (0.407-0.481) 0.0004
24. structured abstract 139 0.802 (0.523-1.047) 25 0.606 (0.445-0.736) 0.0713
25. statistical significance 155 0.802 (0.523-1.047) 9 0.802 (0.344-1.184) 0.9652

* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Article Influence
®
score maintained at 3 decimals as reported in Journal of Citation Reports
®
.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.

32

COMPARISON OF ABSTRACT METRIC (WORD COUNT) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED CHECKLIST QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked word count scores in the
categories of: reporting of adverse effects, structured abstract, statistical significance.

Table 16 - Comparison of abstract metric (word count) with selected CONSORT for RCT Abstracts* modified checklist questions
Q# Key words of the checklist questions Yes Word count
**
No Word count p-value
***

n Median (IQR) n Median (IQR)
1. title participants randomly assigned 101 230 (205-260) 97 241 (205-270) 0.3055
2. design of the trial 65 239 (205-293) 133 231 (205-263) 0.1493
4. trial setting 7 235 (216-275) 191 234 (204-269) 0.4049
9. when the primary outcome was assessed 188 236 (205-270) 10 230 (78-243) 0.3107
12. report about blinding 43 251 (205-292) 155 231 (204-266) 0.1265
13. details about blinding 16 233 (208-276) 182 235 (205-268) 0.6989
14. number of participants randomized to each intervention 52 242 (206-275) 146 231 (205-267) 0.2343
17. effect size 27 251 (203-308) 171 233 (205-266) 0.2438
18. confidence intervals-precision (uncertainty) 12 259 (194-325) 186 234 (205-267) 0.4249
19. adverse (or unexpected) effects 28 265 (224-296) 170 231 (203-265) 0.0095
20. conclusions 183 235 (205-268) 15 231 (114-292) 0.3910
24. structured abstract 165 236 (206-274) 33 231 (184-256) 0.0262
25. statistical significance 183 239 (205-270) 15 212 (114-235) 0.0165

* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Word count rounded off to nearest full number.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.
33

COMPARISON OF ABSTRACT METRIC (NUMBER OF AUTHORS) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED CHECKLIST QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked number of authors scores in the
categories of: reporting of when the primary outcome was assessed.
Table 17 - Comparison of abstract metric (number of authors) with selected CONSORT for RCT Abstracts* modified checklist questions
Q# Key words of the checklist questions Yes Number of
authors
**

No Number of
authors
p-value
***

n Median (IQR) n Median (IQR)
1. title participants randomly assigned 101 5(4-7) 97 5(3-6) 0.2561
2. design of the trial 65 5(4-6) 133 5(4-7) 0.5477
4. trial setting 7 5(3-6) 191 5(4-6) 0.3432
9. when the primary outcome was assessed 188 5(4-7) 10 4(3-5) 0.0357
12. report about blinding 43 5(4-6) 155 5(4-6) 0.4774
13. details about blinding 16 5(5-6) 182 5(4-6) 0.7859
14. number of participants randomized to each intervention 52 5(4-6) 146 5(4-6) 0.4813
17. effect size 27 5(4-7) 171 5(4-6) 0.4066
18. confidence intervals-precision (uncertainty) 12 5(4.5-7) 186 5(4-6) 0.5161
19. adverse (or unexpected) effects 28 5(5-7) 170 5(4-6) 0.3238
20. conclusions 183 5(4-7) 15 5(3-5) 0.1619
24. structured abstract 165 5 (4-6) 33 5(4-7) 0.3786
25. statistical significance 183 5(4-6) 15 4(3-6) 0.1662

* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Number of authors rounded off to nearest full number.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.
34

COMPARISON OF CONTINENTS WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED CHECKLIST QUESTIONS
European countries clearly demonstrated superior reporting in the checklist questions (#1, 12, 13, 17, 18, 20) analyzed below. North America
reported questions about blinding better similar to Europe. It is interesting to note the stark difference in better reporting of effect size and precision
among European countries compared to other countries.
Table 18 - Comparison of continents with selected CONSORT for RCT Abstracts* modified checklist questions
Q# Key words of the checklist questions Continent
Africa Asia Europe North
America
South
America
Total p-
value
**

1. title participants randomly assigned Yes Frequency 3 24 55 7 10 99 0.0001
Percent 1.54 12.31 28.21 3.59 5.13 50.77
No Frequency 4 27 26 26 13 96
Percent 2.05 13.85 13.33 13.33 6.67 49.23

2. design of the trial Yes Frequency 2 12 24 16 10 64 0.1177
Percent 1.03 6.15 12.31 8.21 5.13 32.82
No Frequency 5 39 57 17 13 131
Percent 2.56 20.00 29.23 8.72 6.67 67.18

4. trial setting Yes Frequency 0 2 3 1 1 7 1.0000
Percent 0.00 1.03 1.54 0.51 0.51 3.59
No Frequency 7 49 78 32 22 188
Percent 3.59 25.13 40.00 16.41 11.28 96.41

9. when the primary outcome was assessed Yes Frequency 7 7 78 31 22 185 0.8127
Percent 3.59 3.59 40.00 15.90 11.28 94.87
No Frequency 0 4 3 2 1 10
Percent 0.00 2.05 1.54 1.03 0.51 5.13

12. report about blinding Yes Frequency 1 9 12 15 6 43 0.0106
Percent 0.51 4.62 6.15 7.69 3.08 22.05
No Frequency 6 42 69 18 17 152
Percent 3.08 21.54 35.38 9.23 8.72 77.95

13. details about blinding Yes Frequency 0 0 8 6 2 16 0.0208
35

Table 18 - Comparison of continents with selected CONSORT for RCT Abstracts* modified checklist questions
Q# Key words of the checklist questions Continent
Africa Asia Europe North
America
South
America
Total p-
value
**

Percent 0.00 0.00 4.10 3.08 1.03 8.21
No Frequency 7 51 73 27 21 179
Percent 3.59 26.15 37.44 13.85 10.77 91.79

14. number of participants randomized to
each intervention
Yes Frequency 2 13 24 6 6 51 0.7962
Percent 1.03 6.67 12.31 3.08 3.08 26.15
No Frequency 5 38 57 27 17 144
Percent 2.56 19.49 29.23 13.85 8.72 73.85

17. effect size Yes Frequency 0 2 17 7 1 27 0.0149
Percent 0.00 1.03 8.72 3.59 0.51 13.85
No Frequency 7 49 64 26 22 168
Percent 3.59 25.13 32.82 13.33 11.28 86.15

18. confidence intervals-precision
(uncertainty)
Yes Frequency 0 0 10 1 1 12 0.0424
Percent 0.00 0.00 5.13 0.51 0.51 6.15
No Frequency 7 51 71 32 22 183
Percent 3.59 26.15 36.41 16.41 11.28 93.85

19. adverse (or unexpected) effects Yes Frequency 0 3 14 8 3 28 0.1204
Percent 0.00 1.54 7.18 4.10 1.54 14.36
No Frequency 7 48 67 25 20 167
Percent 3.59 24.62 34.36 12.82 10.26 85.64

20. conclusions Yes Frequency 7 48 78 25 22 180 0.0132
Percent 3.59 24.62 40.00 12.82 11.28 92.31
No Frequency 0 3 3 8 1 15
Percent 0.00 1.54 1.54 4.10 0.51 7.69

24. structured abstract Yes Frequency 6 45 65 29 17 162 0.4906
Percent 3.08 23.08 33.33 14.87 8.72 83.08
No Frequency 1 6 16 4 6 33
Percent 0.51 3.08 8.21 2.05 3.08 16.92

36

Table 18 - Comparison of continents with selected CONSORT for RCT Abstracts* modified checklist questions
Q# Key words of the checklist questions Continent
Africa Asia Europe North
America
South
America
Total p-
value
**

25. statistical significance Yes Frequency 6 48 75 29 22 180 0.6513
Percent 3.08 24.62 38.46 14.87 11.28 92.31
No Frequency 1 3 6 4 1 15
Percent 0.51 1.54 3.08 2.05 0.51 7.69

* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23). ** Fisher’s Exact test was performed. p<0.05 was considered statistically significant.

37

COMPARISON OF JOURNAL (TOP FOUR FREQUENT) METRIC (5-YEAR IMPACT FACTOR) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED
CHECKLIST QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked 5-year impact factor scores
among top 4 frequent journals in the categories of: reporting of details about blinding and adverse effects. Note that low rank of 5-year impact
factor reported adverse events better.
Table 19 - Comparison of journal (top four frequent)# metric (5-year impact factor) with selected CONSORT for RCT Abstracts* modified checklist
questions
Q# Key words of the checklist questions Yes 5-year impact factor
**
No 5-year impact factor p-value
***

n Median (IQR) n Median (IQR)
1. title - participants randomly assigned 62 4.206 (3.083-4.506) 22 3.083 (3.083-4.506) 1.0000
2. design of the trial 26 3.645 (2.694-4.506) 58 3.645 (3.083-4.506) 0.5404
4. trial setting 1 2.694 (2.694-2.694) 83 4.206 (3.083-4.506) 0.1174
9. when the primary outcome was assessed 81 4.206 (3.083-4.506) 3 3.083 (3.083-4.506) 0.9291
12. report about blinding 13 4.506 (3.083-4.506) 71 3.083 (3.083-4.506) 0.2129
13. details about blinding 4 4.506 (4.506-4.506) 80 3.083 (3.083-4.506) 0.0173
14. number of participants randomized to each intervention 26 3.083 (3.083-4.506) 58 4.206 (3.083-4.506) 0.2076
17. effect size 19 4.506 (2.694-4.506) 65 3.083 (3.083-4.506) 0.5962
18. confidence intervals-precision (uncertainty) 12 2.889 (2.694-4.506) 72 4.206 (3.083-4.506) 0.1057
19. adverse (or unexpected) effects 13 3.083 (2.694-4.206) 71 4.206 (3.083-4.506) 0.0412
20. conclusions 84 3.645 (3.083-4.506) 0 ---- ----
24. structured abstract 84 3.645 (3.083-4.506) 0 ---- ----
25. statistical significance 81 3.083 (3.083-4.506) 3 4.206 (3.083-4.506) 0.6656
* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** 5-year impact factor maintained at 3 decimals as reported in Journal of Citation Reports®.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.
#
Top four frequent journals in this study: Journal of periodontology (J Periodontol); Journal of clinical periodontology (J Clin Periodontol); Clinical oral
implants research (Clin Oral Implants Res); European journal of oral implantology (Eur J Oral Implantol)

38

COMPARISON OF JOURNAL (TOP FOUR FREQUENT) METRIC (EIGENFACTOR® SCORE) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED CHECKLIST
QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked Eigenfactor
®
scores in the
categories of: reporting of title, trial design, effect size, confidence interval (precision, uncertainty), adverse effects. Note that in the significant
differences, the better reporting were done in low ranking Eigenfactor
®
scores.
Table 20 - Comparison of journal (top four frequent)# metric (Eigenfactor
®
Score) with selected CONSORT for RCT Abstracts* modified checklist
questions
Q# Key words of the checklist questions Yes Eigenfactor
®
Score ** No Eigenfactor
®
Score p-
value
***
n Median (IQR) n Median (IQR)
1. title - participants randomly assigned 62 0.01478 (0.01478-0.01492) 22 0.01492 (0.01478-0.01492) 0.0175
2. design of the trial 26 0.01478 (0.00130-0.01492) 58 0.01492 (0.01478-0.01492) 0.0248
4. trial setting 1 0.00130 (0.00130-0.00130) 83 0.01492 (0.01478-0.01492) 0.1174
9. when the primary outcome was assessed 81 0.01492 (0.01478-0.01492) 3 0.01492 (0.01478-0.01492) 0.7507
12. report about blinding 13 0.01478 (0.01478-0.01492) 71 0.01492 (0.01478-0.01492) 0.7493
13. details about blinding 4 0.01478 (0.01478-0.01478) 80 0.01492 (0.01478-0.01492) 0.1596
14. number of participants randomized to each intervention 26 0.01485 (0.01478-0.01492) 58 0.01492 (0.01478-0.01492) 0.7248
17. effect size 19 0.01478 (0.00130-0.01478) 65 0.01492 (0.01478-0.01492) 0.0010
18. confidence intervals-precision (uncertainty) 12 0.00804 (0.00130-0.01478) 72 0.01492 (0.01478-0.01492) 0.0018
19. adverse (or unexpected) effects 13 0.01478 (0.00130-0.01492) 71 0.01492 (0.01478-0.01492) 0.0309
20. conclusions 84 0.01492 (0.01478-0.01492) 0 ---- ----
24. structured abstract 84 0.01492 (0.01478-0.01492) 0 ---- ----
25. statistical significance 81 0.01492 (0.01478-0.01492) 3 0.01492 (0.01478-0.01536) 0.3874
* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Eigenfactor® score maintained at 5 decimals as reported in Journal of Citation Reports®.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.

39

COMPARISON OF JOURNAL (TOP FOUR FREQUENT)# METRIC (ARTICLE INFLUENCE® SCORE) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED
CHECKLIST QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked Article Influence
®
Score in the
categories of: reporting details about blinding and adverse effects. Note that the lower ranks of Article Influence
®
Score reported adverse effects
better.
Table 21 – Comparison of journal (top four frequent)# metric (Article Influence® Score) with selected CONSORT for RCT Abstracts* modified checklist
questions
Q# Key words of the checklist questions Yes Article Influence
®
Score
**
No Article Influence
®
Score p-
value
***
n Median (IQR) n Median (IQR)
1. title - participants randomly assigned 62 1.016 (0.802-1.184) 22 0.802 (0.802-1.184) 1.0000
2. design of the trial 26 0.909 (0.631-1.184) 58 0.909 (0.802-1.184) 0.5404
4. trial setting 1 0.631 (0.631-0.631) 83 1.016 (0.802-1.184) 0.1174
9. when the primary outcome was assessed 81 1.016 (0.802-1.184) 3 0.802 (0.802-1.184) 0.9291
12. report about blinding 13 1.184 (0.802-1.184) 71 0.802 (0.802-1.184) 0.2129
13. details about blinding 4 1.184 (1.184-1.184) 80 0.802 (0.802-1.184) 0.0173
14. number of participants randomized to each intervention 26 0.802 (0.802-1.184) 58 1.016 (0.802-1.184) 0.2076
17. effect size 19 1.184 (0.631-1.184) 65 0.802 (0.802-1.184) 0.5962
18. confidence intervals-precision (uncertainty) 12 0.717 (0.631-1.184) 72 1.016 (0.802-1.184) 0.1057
19. adverse (or unexpected) effects 13 0.802 (0.631-1.016) 71 1.016 (0.802-1.184) 0.0412
20. conclusions 84 0.909 (0.802-1.184) 0 ---- ----
24. structured abstract 84 0.909 (0.802-1.184) 0 ---- ----
25. statistical significance 81 0.802 (0.802-1.184) 3 1.016 (0.802-1.184) 0.6656
* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Article Influence® score maintained at 3 decimals as reported in Journal of Citation Reports®.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.

40

COMPARISON OF ABSTRACT (TOP FOUR FREQUENT JOURNALS) METRIC (WORD COUNT) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED
CHECKLIST QUESTIONS
The results suggest that there is no statistically significant difference between the underlying distributions of the ranked word count scores in any of
the questionnaire items.
Table 22 - Comparison of abstract (top four frequent journals)# metric (word count) with selected CONSORT for RCT Abstracts* modified checklist
questions
Q# Key words of the checklist questions Yes Word count
**
No Word count p-value
***

n Median (IQR) n Median (IQR)
1. title participants randomly assigned 62 231 (201-260) 22 250 (220-266) 0.1090
2. design of the trial 26 243 (203-320) 58 234 (208-260) 0.3971
4. trial setting 1 216 (216-216) 83 239 (206266) 0.6352
9. when the primary outcome was assessed 81 236 (207-266) 3 242 (206-243) 0.7724
12. report about blinding 13 243 (230-260) 71 236 (206-266) 0.5042
13. details about blinding 4 231 (221-233) 80 240 (206-266) 0.5849
14. number of participants randomized to each intervention 26 237 (201-278) 58 238 (208-262) 0.7642
17. effect size 19 231 (199-289) 65 239 (211-262) 0.6766
18. confidence intervals-precision (uncertainty) 12 259 (194-325) 72 235 (208-261) 0.4940
19. adverse (or unexpected) effects 13 251 (199-321) 71 236 (207-262) 0.4143
20. conclusions 84 238 (207-264) 0 ---- ----
24. structured abstract 84 238 (207-264) 0 ---- ----
25. statistical significance 81 239 (206-266) 3 212 (211-251) 0.6469
* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Word count rounded off to nearest full number.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.
#Top four frequent journals in this study: Journal of periodontology (J Periodontol); Journal of clinical periodontology (J Clin Periodontol); Clinical oral
implants research (Clin Oral Implants Res); European journal of oral implantology (Eur J Oral Implantol)

41

COMPARISON OF ABSTRACT (TOP FOUR FREQUENT JOURNALS) METRIC (NUMBER OF AUTHORS) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED
CHECKLIST QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked number of authors scores in the
item of reporting about blinding.
Table 23 - Comparison of abstract (top four frequent journals)# metric (number of authors) with selected CONSORT for RCT Abstracts* modified
checklist questions
Q# Key words of the checklist questions Yes Number of
authors
**

No Number of
authors
p-value
***

n Median (IQR) n Median (IQR)
1. title participants randomly assigned 62 5 (4-7) 22 5 (3-8) 0.9918
2. design of the trial 26 6 (5-8) 58 5 (4-7) 0.1535
4. trial setting 1 5 (5-5) 83 5 (4-7) 0.8187
9. when the primary outcome was assessed 81 5 (4-7) 3 5 (4-6) 0.6968
12. report about blinding 13 6 (5-8) 71 5 (4-7) 0.0311
13. details about blinding 4 5 (5-6) 80 5 (4-7) 0.9492
14. number of participants randomized to each intervention 26 5 (4-6) 58 6 (4-8) 0.2447
17. effect size 19 6 (5-8) 65 5 (4-7) 0.2263
18. confidence intervals-precision (uncertainty) 12 5 (5-7) 72 5 (4-7) 0.8514
19. adverse (or unexpected) effects 13 6 (5-6) 71 5 (4-7) 0.3115
20. conclusions 84 5 (4-7) 0 ---- ----
24. structured abstract 84 5 (4-7) 0 ---- ----
25. statistical significance 81 5 (4-7) 3 3 (2-10) 0.4725
* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Number of authors rounded off to nearest full number.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.
#Top four frequent journals in this study: Journal of periodontology (J Periodontol); Journal of clinical periodontology (J Clin Periodontol); Clinical oral
implants research (Clin Oral Implants Res); European journal of oral implantology (Eur J Oral Implantol)

42

COMPARISON OF COUNTRY (TOP SEVEN FREQUENT) METRIC (5-YEAR IMPACT FACTOR) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED
CHECKLIST QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked 5-year impact factor scores
among top 4 frequent journals in the item of reporting randomization in the title, conclusions.
Table 24 - Comparison of country (top seven frequent)# metric (5-year impact factor) with selected CONSORT for RCT Abstracts* modified checklist
questions
Q# Key words of the checklist questions Yes 5-year impact factor
**
No 5-year impact factor p-value
***

n Median (IQR) n Median (IQR)
1. title - participants randomly assigned 58 3.083 (2.694-4.506) 47 2.603 (1.685-3.083) 0.0056
2. design of the trial 32 2.694 (1.977-3.083) 73 3.083 (2.239-4.015) 0.0836
4. trial setting 1 2.694 (2.694-2.694) 104 3.083 (2.037-3.865) 0.7515
9. when the primary outcome was assessed 101 3.083 (2.239-3.713) 4 3.083 (2.384-3.795) 0.6786
12. report about blinding 22 3.083 (1.504-4.506) 83 3.083 (2.485-3.713) 0.9303
13. details about blinding 9 1.714 (1.504-4.506) 96 3.083 (2.362-3.713) 0.6687
14. number of participants randomized to each intervention 34 2.889 (1.710-3.713) 71 3.083 (2.239-4.015) 0.8437
17. effect size 17 3.083 (2.694-4.506) 88 3.083 (1.714-3.713) 0.0737
18. confidence intervals-precision (uncertainty) 11 2.694 (2.694-4.506) 94 3.083 (1.714-3.713) 0.2181
19. adverse (or unexpected) effects 18 2.694 (1.641-3.083) 87 3.083 (2.239-4.206) 0.2307
20. conclusions 100 3.083 (2.362-4.015) 5 1.504 (1.504-1.504) 0.0067
24. structured abstract 91 3.083 (2.239-3.713) 14 2.600 (1.714-4.015) 0.2338
25. statistical significance 101 3.083 (2.239-3.713) 4 2.782 (1.240-4.261) 0.7672
* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** 5-year impact factor maintained at 3 decimals as reported in Journal of Citation Reports®.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.
#
Top seven frequent countries in this study that published >10 RCTs in 2012 in ‘Periodontal Diseases’: USA, India, Italy, Brazil, Turkey, Germany, and
Sweden.

43

COMPARISON OF COUNTRY (TOP SEVEN FREQUENT) METRIC (EIGENFACTOR® SCORE) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED
CHECKLIST QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked Eigenfactor
®
scores in the
categories of: reporting of trial design, confidence intervals (precision-uncertainty), and adverse effects. Note that in the significant differences, the
better reporting were done in low ranking Eigenfactor
®
scores.
Table 25 - Comparison of country (top seven frequent)
#
metric (Eigenfactor
®
Score) with selected CONSORT for RCT Abstracts* modified checklist
questions
Q# Key words of the checklist questions Yes Eigenfactor
®
Score ** No Eigenfactor
®
Score p-
value
***
n Median (IQR) n Median (IQR)
1. title - participants randomly assigned 60 0.01478 (0.00236-0.01492) 49 0.00505 (0.00323-0.01492) 0.6098
2. design of the trial 34 0.00363 (0.00130-0.01478) 75 0.01478 (0.00369-0.01492) 0.0003
4. trial setting 1 0.00130 (0.00130-0.00130) 108 0.01437 (0.00270-0.01492) 0.1535
9. when the primary outcome was assessed 105 0.00785 (0.00241-0.01492) 4 0.01492 (0.01485-0.01655) 0.0463
12. report about blinding 22 0.01478 (0.00241-0.01492) 87 0.00930 (0.00270-0.01492) 0.8789
13. details about blinding 9 0.00241 (0.00241-0.01478) 100 0.01437 (0.00270-0.01492) 0.4173
14. number of participants randomized to each intervention 36 0.00950 (0.00210-0.01492) 73 0.01478 (0.00270-0.01492) 0.6797
17. effect size 17 0.01478 (0.00130-0.01478) 92 0.01163 (0.00297-0.01492) 0.0655
18. confidence intervals-precision (uncertainty) 11 0.00130 (0.00130-0.01478) 98 0.01437 (0.00270-0.01492) 0.0449
19. adverse (or unexpected) effects 18 0.00256 (0.00130-0.01478) 91 0.01478 (0.00369-0.01492) 0.0191
20. conclusions 104 0.01478 (0.00270-0.01492) 5 0.00241 (0.00241-0.00241) 0.0583
---- structured abstract 93 0.01478 (0.00270-0.01492) 16 0.00586 (0.00207-0.01932) 0.5684
---- statistical significance 104 0.01437 (0.00270-0.01492) 5 0.00270 (0.00192-0.01478) 0.4648
* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Eigenfactor® score maintained at 5 decimals as reported in Journal of Citation Reports®.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.
#Top seven frequent countries in this study that published >10 RCTs in 2012 in ‘Periodontal Diseases’: USA, India, Italy, Brazil, Turkey, Germany, and
Sweden.
44

COMPARISON OF COUNTRY (TOP SEVEN FREQUENT METRIC (ARTICLE INFLUENCE
®
SCORE) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED
CHECKLIST QUESTIONS
The results suggest that there is a statistically significant difference between the underlying distributions of the ranked Article Influence
®
Score in the
categories of: reporting title, trial design and conclusions. Note that the lower ranks of Article Influence
®
Score reported title and trial design better.
Table 26 - Comparison of country (top seven frequent)
#
metric (Article Influence
®
Score) with selected CONSORT for RCT Abstracts* modified
checklist questions
Q# Key words of the checklist questions Yes Article Influence
®
Score
**
No Article Influence
®
Score p-
value
***
n Median (IQR) n Median (IQR)
1. title - participants randomly assigned 58 0.802 (0.631-1.184) 47 1.184 (0.407-0.820) 0.0123
2. design of the trial 32 0.631 (0.499-0.802) 73 0.802 (0.553-1.047) 0.0325
4. trial setting 1 0.631 (0.631-0.631) 104 0.802 (0.538-1.047) 0.6054
9. when the primary outcome was assessed 101 0.802 (0.553-1.047) 4 0.802 (0.642-0.993) 0.6910
12. report about blinding 22 0.802 (0.407-1.184) 83 0.802 (0.606-1.047) 0.8924
13. details about blinding 9 0.445 (0.407-1.184) 96 0.802 (0.580-1.047) 0.8714
14. number of participants randomized to each intervention 34 0.802 (0.510-1.016) 71 0.802 (0.553-1.184) 0.7476
17. effect size 17 0.802 (0.631-1.184) 88 0.802 (0.507-1.016) 0.2104
18. confidence intervals-precision (uncertainty) 11 0.631 (0.631-1.184) 94 0.802 (0.504-1.047) 0.5020
19. adverse (or unexpected) effects 18 0.631 (0.504-0.802) 87 0.802 (0.553-1.184) 0.2020
20. conclusions 100 0.802 (0.580-1.047) 5 0.407 (0.407-0.407) 0.0109
24. structured abstract 91 0.802 (0.553-1.047) 14 0.606 (0.445-1.369) 0.7210
25. statistical significance 101 0.802 (0.553-1.047) 4 0.764 (0.310-1.277) 0.9259
* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Article Influence® score maintained at 3 decimals as reported in Journal of Citation Reports®.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.
#Top seven frequent countries in this study that published >10 RCTs in 2012 in ‘Periodontal Diseases’: USA, India, Italy, Brazil, Turkey, Germany, and
Sweden.

45

COMPARISON OF COUNTRY (TOP SEVEN FREQUENT) METRIC (WORD COUNT) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED CHECKLIST
QUESTIONS
The results suggest that there is statistically significant difference between the underlying distributions of the ranked word count scores in the
reporting of adverse effects.
Table 27 - Comparison of country (top seven frequent)# metric (word count) with selected CONSORT for RCT Abstracts* modified checklist questions
Q# Key words of the checklist questions Yes Word count
**
No Word count p-value
***

n Median (IQR) n Median (IQR)
1. title participants randomly assigned 66 227 (201-266) 63 241 (205-270) 0.4056
2. design of the trial 39 239 (205-300) 90 231 (201-265) 0.1685
4. trial setting 2 246 (216-275) 127 234 (204-270) 0.7315
9. when the primary outcome was assessed 121 234 (205-270) 8 235 (142-259) 0.6603
12. report about blinding 28 248 (201-283) 101 231 (205-266) 0.6051
13. details about blinding 10 233 (205-277) 119 236 (204-270) 0.7916
14. number of participants randomized to each intervention 39 249 (205-278) 90 228 (204-267) 0.0997
17. effect size 18 231 (199-308) 111 236 (205-270) 0.7727
18. confidence intervals-precision (uncertainty) 11 266 (189-341) 118 234 (205-269) 0.5052
19. adverse (or unexpected) effects 21 286 (230-303) 108 230 (200-264) 0.0033
20. conclusions 121 233 (205-270) 8 252 (116-294) 0.9222
24. structured abstract 109 233 (205-275) 20 237 (188-261) 0.1458
25. statistical significance 119 237 (205-274) 10 219 (119-228) 0.0796
* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Word count rounded off to nearest full number.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.
#Top seven frequent countries in this study that published >10 RCTs in 2012 in ‘Periodontal Diseases’: USA, India, Italy, Brazil, Turkey, Germany, and
Sweden.

46

COMPARISON OF COUNTRY (TOP SEVEN FREQUENT) METRIC (NUMBER OF AUTHORS) WITH SELECTED CONSORT FOR RCT ABSTRACTS MODIFIED CHECKLIST
QUESTIONS
The results suggest that there is no statistically significant difference between the underlying distributions of the ranked number of authors in the items
of reporting.
Table 28 - Comparison of country (top seven frequent)# metric (number of authors) with selected CONSORT for RCT Abstracts* modified checklist
questions
Q# Key words of the checklist questions Yes Number of
authors
**

No Number of
authors
p-value
***

n Median (IQR) n Median (IQR)
1. title participants randomly assigned 66 5 (4-6) 63 5 (3-7) 0.7387
2. design of the trial 39 5 (4-7) 90 5 (3-6) 0.1775
4. trial setting 2 4 (2-5) 127 5 (4-6) 0.2553
9. when the primary outcome was assessed 121 5 (4-7) 8 4 (4-5) 0.1085
12. report about blinding 28 6 (5-7) 101 5 (4-6) 0.1032
13. details about blinding 10 5 (5-6) 119 5 (4-6) 0.9858
14. number of participants randomized to each intervention 39 5 (3-6) 90 5 (4-7) 0.2659
17. effect size 18 5 (5-7) 111 5 (4-6) 0.1986
18. confidence intervals-precision (uncertainty) 11 5 (5-8) 118 5 (4-6) 0.2788
19. adverse (or unexpected) effects 21 5 (4-6) 108 5 (4-6) 0.4620
20. conclusions 121 5 (4-7) 8 5 (5-6) 0.6284
---- structured abstract 109 5 (4-6) 20 6 (4-8) 0.2604
---- statistical significance 119 5 (4-6) 10 5 (4-6) 0.6432
* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Number of authors rounded off to nearest full number.
*** Wilcoxon rank-sum test (Mann–Whitney U test), two-sample test was performed. Two-sided probability: p<0.05 considered statistically significant.
#Top seven frequent countries in this study that published >10 RCTs in 2012 in ‘Periodontal Diseases’: USA, India, Italy, Brazil, Turkey, Germany, and
Sweden.

47

COMPARISON OF RCT ABSTRACTS PUBLISHED IN CONSORT ENDORSING JOURNALS# (N=108) WITH SELECTED CONSORT FOR RCT ABSTRACTS* MODIFIED
CHECKLIST QUESTIONS
The results suggest that there is no statistically significant difference between CONSORT endorsing and CONSORT non-endorsing journals per the
CONSRT website list in the items of reporting except title (mention randomization in the title) and structured abstract.
Table 29 - Comparison of RCT Abstracts published in CONSORT endorsing journals
#
(n=108) with selected CONSORT for RCT Abstracts* modified
checklist questions
Q# Key words of the checklist questions Yes No
p-value
**

n (%) n (%)
1. title - participants randomly assigned 64 44 0.0110
2. design of the trial 33 75 0.4557
4. trial setting 2 106 0.1600
9. when the primary outcome was assessed 103 5 0.7670
12. report about blinding 24 84 0.8502
13. details about blinding 11 97 0.2340
14. number of participants randomized to each intervention 26 82 0.4433
17. effect size 17 91 0.3445
18. confidence intervals-precision (uncertainty) 6 102 0.7442
19. adverse (or unexpected) effects 12 96 0.1801
20. conclusions 101 7 0.5238
---- structured abstract 98 10 0.0022
---- statistical significance 101 7 0.5238

#
Information about CONSORT Endorsement by the journals was obtained from the CONSORT website only which lists all the 585 journals currently
endorsing CONSORT guidelines. Accessed on May 20, 015. Fifteen journals in this study contributing a total of 108 RCTs are listed in CONSORT website
as CONSORT Endorsers. http://www.consort-statement.org/about-consort/endorsers
* Checklist questions (3, 5-8, 10, 11, 15, 16, 21-23) that had total responses ranging between ≤5 and ≥189 out of 198 abstracts surveyed were
excluded from all comparisons with journal and abstract metrics. These items were consistently either always reported (3, 5-8, 16) or never reported
(10, 11, 15, 21-23).
** Chi-square test was performed; p<0.05 considered statistically significant.

48

CHAPTER 4 – DISCUSSION

A cross-sectional survey was designed and executed to understand in detail the quality of
reporting of RCT of periodontal diseases in journal abstracts. CONSORT RCT Abstract extension was used as
a template and a modified checklist with 25 questions was used to assess the same in 198 RCT abstracts
published in the year 2012 in journals indexed in PubMed. To understand if there is any association with the
bibliometric of the journals, bibliometric analysis was conducted.
DIFFERENCES AND SIMILARITIES IN METHODOLOGY FROM PREVIOUS STUDIES
This study differs from previous studies (Faggion and Giannakopoulos, 2012; Fleming et al., 2012;
Kiriakou et al., 2014; Seehra et al., 2013) reporting on the quality of RCT abstracts in dentistry as below:
- All journals irrespective of their metric or ranking was included that reported RCT on periodontal
diseases unlike the previous reports which focused mainly on high impact specialty journals.
- This study focused the assessment of all studies on the clinical entity ‘periodontal diseases’. The
MeSH search term was used for this purpose. This approach allows evaluating a reasonable
number of RCT from all Medline indexed journals in a specific topic thereby preventing selection
bias restricted to a small group of journals.
- Comparison of selected checklist questions that showed discrepancy between the RCT abstracts
with relevant journal metrics (5-year impact factor, Eigenfactor score and Article Influence score)
was performed.
- Subgroup analyses of most frequent journals and countries publishing the most number of RCT in
the selected time frame of 2012.
This study is similar in some manner to previous studies (Faggion and Giannakopoulos, 2012; Fleming
et al., 2012; Kiriakou et al., 2014; Seehra et al., 2013) reporting on the quality of RCT abstracts in dentistry as
below:
49

- A modified checklist with detailed, focused questions with additional ‘notes’ using the CONSORT
RCT Abstract extension with explanation and elaboration document as the template was used to
assess reporting. Although the modification is similar in general to previous studies, detailed
focused question based assessment was made. The goal was to decrease ambiguity as much as
possible so that the entire assessment can be made by one person and reduce the need to get a
second opinion. This can be tested for reliability and validity with two or more evaluators in the
future studies. In addition, ‘split mouth’ design was added and scored ‘yes’ in trial design as it is a
common study design in dental research though it has its own limitations as described elsewhere
(Lesaffre et al., 2009). Additional useful data gathered included whether the abstract was written in
a structured format and whether the abstract reported statistical significance with or without a ‘p’
value (Fleming et al., 2012; Kiriakou et al., 2014; Seehra et al., 2013).
- Comparison of selected checklist questions that showed discrepancy between the RCT abstracts
with relevant abstract metrics (number of authors and word count) was performed (Fleming et al.,
2012; Kiriakou et al., 2014; Seehra et al., 2013).
- Comparison of selected checklist questions that showed discrepancy between the journals with
the geographic distribution of RCT publications was studied (Fleming et al., 2012; Kiriakou et al.,
2014; Seehra et al., 2013).
CONSORT RCT IN JOURNAL ABSTRACTS - MODIFIED CHECKLIST (25 QUESTIONS)
During the conception of this survey, it was noted that the original checklist items (Hopewell et al.,
2008a) had few words to describe each item whereas the accompanying explanation and elaboration
article (Hopewell et al., 2008b) gave much more detailed information that made assessment of RCT
abstracts much easier. Previous authors have modified the checklist but they reported some difficulty in
certain checklist items mainly due to misinterpretation of definitions (Faggion and Giannakopoulos, 2012;
Seehra et al., 2013). Hence, having a detailed checklist question may improve this situation and the
CONSORT RCT explanation and elaboration document was used as a template to create a checklist of
questions. The main hope behind this approach is that any individual would be able to evaluate an RCT
abstract with a simple check ‘yes’ or ‘no’ without much ambiguity.
50

MEDLINE SEARCH PROCESS – LESSONS LEARNED
This study underscored the importance of filters built in literature databases. Despite using strict
filters within PubMed search (Languages, Species, Randomized Controlled Trials, and Publication Dates),
several articles that did not meet the filter were obtained during the initial search. Only the filter language
was 100% accurate with no foreign language citations was obtained. However, animal study, in vitro
studies, observational studies, studies outside the publication dates specified were all obtained using these
filters. Rather than pointing at the database filters for such inaccuracies, the first approach would be have
authors, editors take responsibility in identifying the relevant fields such as accurate study design, species,
whether it is a clinical study using keywords for accurate indexing. For instance, in this study, about 50% of
RCT did not report in the title as a randomized study when in fact they were. Such omissions may lead to
inaccurate indexing and may never get retrieved for future secondary research such as systematic reviews.
MEDLINE SUBJECT HEADING (MESH) ‘PERIODONTAL DISEASES’
The rationale for using the MeSH term ‘Periodontal Diseases’ (Appendix C) is mainly for the search
reproducibility. PubMed defines each MeSH term in detail and the researcher exactly knows what is
included in the search filter (PubMed). However, this filter also has a drawback of excluding studies that are
not indexed accurately due to various factors including those of the authors, journal editors, publishers, and
the database software. The main aim of this study is not to be comprehensive in procuring as many RCT
abstracts as possible but to get a broad sense of what the quality of RCT abstract reporting in all the
PubMed indexed journals in a specific topic. Hence, reproducibility and focused search with clear
definitions was made priorities. MeSH includes ‘apical periodontitis’ under ‘Periodontal Diseases’ which led
to search output with few RCT in Endodontics (Appendix F & G). They were eliminated from this study during
the initial eligibility screening. PubMed has introduced several clinical filters (PubMed) including those
specific for clinical trials. The filter of ‘Randomized Controlled Trials’ was used in this study. The fact that
about 50% of RCT abstracts evaluated in this study did not mention that their study is ‘randomized’ and that
PubMed was still able to filter them is noteworthy. On the other hand, authors and editors need to be wary
that it is also likely that PubMed can exclude these trials from a simple filter based search. Hence, impact of
these studies may not reach the audience (clinicians, researchers, exclusion in systematic reviews) at all
levels effectively.
51

BIBLIOMETRICS – JOURNAL AND ABSTRACT METRICS
This study evaluated in detail three major journal metrics (5-year impact factor, Eigenfactor score
and Article Influence score) and compared with the RCT abstract reporting. It was interesting to note that
the majority of the checklist questions analyzed, there was no statistically significant association between
the journals’ metrics and the compliance with essential reporting. Interestingly, lower ranked journals in
terms of these metrics reported certain items relatively better than higher ranked journals. This is important
because the previous studies focused mainly on the specialty journals. The findings from this study
underscores the fact that higher impact scores does not necessarily mean better reporting of RCT abstracts
across the board. There is room for improvement for all journals irrespective of their metrics.
Similar conclusion can be drawn in terms of word count and number of authors as well. Relatively
better reporting was noted within the recommended 250-300 words by CONSORT almost always. A
consistently good reporting in compliance to include all essential RCT abstract items should be feasible
between 250-300 words (Hopewell et al., 2008b). This observation on word count has been well
documented in previous studies as well (Fleming et al., 2012; Kiriakou et al., 2014; Seehra et al., 2013).
Hence, authors and editors should make an effort to include all the items and not point to the word limit
restriction as the cause for poor reporting.
GEOGRAPHIC DISTRIBUTION
While Europe clearly dominated this sample of RCT abstracts with 81 trials, Asian countries have
contributed 51 trials to literature. India in Asia and Brazil in South America are two of the top four countries
contributing to this study besides USA and Italy. This shows the growing influence of developing nations in
conducting RCT as was also noted in a recent bibliometric study (Geminiani et al., 2014). The relatively
better reporting by European nations was also noted in previous studies (Fleming et al., 2012; Kiriakou et al.,
2014).
CONSORT RCT ABSTRACT REPORTING
Overall, the results of this study is in agreement with previous studies (Faggion and Giannakopoulos,
2012; Fleming et al., 2012; Kiriakou et al., 2014; Seehra et al., 2013) with good reporting of experimental
interventions (checklist question #5), participant eligibility criteria (#3); comparison interventions (#6);
52

specific objective or hypothesis (#7); primary outcome (#8); and reporting trial results as a summary (#16)
and poor reporting on how the allocations were concealed (#11), source of funding for the trials (#23),
number of participants included in the analysis for each intervention (#10); trial registration number (#15);
name of trial register (#21) ; and how the randomization or sequence generation was done (#22). Dismal
reporting was noted in many checklist questions including the Identification of the study as randomized in
the title, design of the trial, trial setting, randomization, blinding, number of participants actually receiving
the intervention and those who were eventually analyzed, effect size, precision of the estimate of the
effect, and adverse effects. Direct comparison with these studies was not possible as three studies (Fleming
et al., 2012; Kiriakou et al., 2014; Seehra et al., 2013) used a ‘scoring’ system of ‘no description’,
‘inadequate’, and ‘adequate’ whereas a simple dichotomous ‘yes’ or ‘no’ was used in this study.
Nevertheless, the findings are similar and the overall conclusions on suboptimal reporting remain
unchanged. Another study (Faggion and Giannakopoulos, 2012)exclusively done in periodontology and
implant dentistry used a shortened version of 15-item checklist with dichotomous approach and the results
were similar again. The authors also compared pre- and post-CONSORT samples to see whether there is
any improvement in RCT abstract reporting. It is encouraging to note that there was some improvement in
certain items post-CONSORT sample. This has also been noted by other studies to underscore the fact the
compliance to CONSORT guidelines improves better reporting and hence better clarity for the consumers
of this body of research (Hopewell et al., 2012) but there is still room for improvement (Can et al., 2011; Cui
et al., 2014; Ghimire et al., 2014; Mbuagbaw et al., 2014).
CONSORT ENDORSEMENT
Despite majority of RCT (108/198) were published in journals which were listed as CONSORT
endorsing journals (15/57) as of May 2015 (CONSORT), it was surprising to note that there was no statistically
significant difference in the most of the checklist questions of the quality of reporting when compared with
journals that were not listed in the CONSORT website. The only exception in the recommended items was
that the CONSORT endorsing journals reported the title as randomized study relatively better. Also, the
abstracts tended to be structured in CONSORT endorsing journals. Besides these two observations, the
quality of reporting on the actual study design, conduct, analyses, funding, among others were all similar to
those RCT abstracts published in the remaining journals not listed as CONSORT endorsers. The previous
53

studies reported in dentistry did not include a wide gamut of journals such as this study and hence a direct
comparison is not feasible (Faggion and Giannakopoulos, 2012; Fleming et al., 2012; Kiriakou et al., 2014;
Seehra et al., 2013). This finding is important to alert the journal editors, especially those who have already
listed as CONSORT endorsing journals, to be more vigilant and implement adherence in the quality of
reporting per CONSORT standards (Jull and Aye, 2015; Smith et al., 2015; Turner et al., 2012).
STATISTICAL SIGNIFICANCE, EFFECT SIZE AND UNCERTAINTY
Though not part of the essential checklist item in CONSORT, it was interesting to note that 92.4% of
RCT abstracts reported ‘statistical significance’ but only 13.6% and 6.1% reported on the effect size, and
precision of the estimate of the effect respectively. This is of concern because over emphasis on statistical
significance has been shown to be associated with misinterpretation of research studies (Sullivan and Feinn,
2012). This finding is consistent in most of the studies published previously (Fleming et al., 2012; Kiriakou et al.,
2014; Seehra et al., 2013). Research has shown that ‘spin’ which is the special emphasis on beneficial effect
of experimental treatment such as the statistical significance (Boutron et al., 2010) in an RCT abstract can
cause misrepresentation of the research and can have profound negative impact by spreading in the
news media and press releases (Boutron et al., 2014; Yavchitz et al., 2012).
STRUCTURED ABSTRACTS
Thirty-three RCT abstracts of 198 did not have a structured abstract in this study. Structured
abstracts are essential for better reporting and easy understanding (Fontelo et al., 2013; Scherer and
Crawley, 1998; Sharma and Harrison, 2006). During the analysis of this study, it was clear that abstracts that
had no structure reported the abstract of the study poorly in general.
STRENGTHS AND LIMITATIONS
This study provides in depth analysis of the reporting quality of RCT abstracts in 57 journals across 38
countries. This reporting was associated with salient journal metrics and abstract metrics. This is a cross-
sectional survey and was conducted primarily by one examiner (SK). However, the evaluation was done
after calibration exercise with high intra-rater agreement of k=0.91. The premise of this decision is to be able
to use such a checklist of questions for an objective evaluation of an abstract by an individual healthcare
provider rather than multiple examiners. However, this has to be substantiated by future studies by
54

comparing calibrated and non-calibrated intra-rater and inter-rater assessments. In addition, a second
reviewer (HM) familiar with the study concept, design and analyses of the modified checklist of questions
was consulted (Appendix H) who independently evaluated the checklist questions and provided input on
selected items where the primary examiner had equivocal interpretations. Majority of the responses of
secondary examiner were identical to the primary examiner.
RECOMMENDATIONS FOR FUTURE RESEARCH
Novel and simple ways to improve the reporting of RCT Abstract should be devised and tested. For
example, an electronic checklist while uploading the manuscript for publication can be tested for
compliance and improved reporting. Published abstracts indexed in PubMed can be rewritten with the
appropriate permissions and tested for understanding, dissemination and application in clinical care.
Authors should resort to transparent reporting and journal editors should only accept RCT abstracts with all
essential items reported. Adherence to established reporting standards can be studied in detail over a
period of time to encourage better reporting.

55

CHAPTER 5 – CONCLUSION
The reporting quality of RCT of periodontal diseases in the journal abstracts published in 2012 is poor in
many essential CONSORT RCT abstract modified checklist questions. These items have been identified
clearly to help all stakeholders – authors, clinicians, researchers, peer reviewers, journal editors, and
publishers to take note and help with the improvement of the same. Despite some significant differences in
the bibliometric factors analyzed with better reporting, the results overall failed to reject the null hypothesis
that there is no association between the journal metrics, word count, number of authors, CONSORT
endorsement and the quality of reporting of CONSORT RCT abstract modified checklist questions.

56

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62

Appendix A - Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomized Controlled
Trials in Journal and Conference Abstracts - Original Checklist (17 Items with Description)

*This item is specific to conference abstracts.
Reference: Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF; CONSORT Group.
CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and
elaboration. PLoS Med. 2008 Jan 22;5(1):e20.
Item Description

Title Identification of the study as randomized
Authors * Contact details for the corresponding author
Trial design Description of the trial design (e.g. parallel, cluster, non-inferiority)
Methods
Participants Eligibility criteria for participants and the settings where the data were
collected
Interventions Interventions intended for each group
Objective Specific objective or hypothesis
Outcome Clearly defined primary outcome for this report
Randomization How participants were allocated to interventions
Blinding (masking) Whether or not participants, care givers, and those assessing the outcomes
were blinded to group assignment
Results
Numbers randomized Number of participants randomized to each group
Recruitment Trial status
Numbers analyzed Number of participants analyzed in each group
Outcome

For the primary outcome, a result for each group and the estimated effect
size and its precision
Harms Important adverse events or side effects
Conclusions General interpretation of the results
Trial registration Registration number and name of trial register
Funding Source of funding
63

Appendix B - Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomized Controlled Trials in Journal Abstracts – Modified
Checklist (25 Questions)
Item
**
Description Q# In the RCT abstract being assessed, did the authors
Title Identification of the study
as randomized
1. state explicitly in the title that the participants were randomly assigned
to their comparison groups?
Yes No
Trial Design Description of the trial
design (e.g. parallel,
cluster, non-inferiority)
2. describe the design of the trial (e.g., parallel group, cluster randomized,
crossover, factorial, superiority, equivalence or noninferiority, or some
other combination of these designs)?
Note: Select ‘yes’ if split-mouth design is mentioned.
Yes No
Methods Participants Eligibility criteria for
participants and the
settings where the data
were collected
3. describe the participant eligibility criteria that may relate to
demographics, clinical diagnosis, and comorbid conditions?
Yes No
4. provide a clear description of the trial setting in which they were
studied, so that readers may assess the external validity (generalizability)
of the trial and determine its applicability to their own setting?
Note: Please note that this is the location(s) of the trial such as the
University or private clinic, not where the participants come from.
Yes No
Interventions Interventions intended for
each group
5. describe the essential features of the experimental interventions? Yes No
6. describe the essential features of comparison interventions? Yes No
Objective Specific objective or
hypothesis
7. provide a clear statement of the specific objective or hypothesis
addressed in the trial?
Yes No
Outcome Clearly defined primary
outcome for this report
8. explicitly state the primary outcome for the trial? Yes No
9. explicitly state when the primary outcome was assessed (e.g., the time
frame over which it was measured)?
Yes No
Randomization How participants were
allocated to interventions
10. report how the randomization or sequence generation was done (e.g.,
use of computer or random number table)?
Yes No
11. describe how the allocations were concealed (e.g., sequentially
numbered, opaque sealed envelopes)?
Yes No
Blinding
(Masking)
Whether or not
participants, care givers,
and those assessing the
outcomes were blinded to
group assignment
12. report about blinding?
Note: Select 'yes' if the authors mention about blinding with less well-
understood terms such as ‘single’ or ‘double’ blind that CONSORT
recommends that authors should avoid.
Yes No
13. describe whether or not participants, those administering the
intervention (usually health-care providers), and those assessing the
outcome (the data collectors and analysts) were blinded to the group
allocation?
Yes No
Results Numbers
Randomized
Number of participants
randomized to each
group
14. report the number of participants randomized to each intervention?
Note: Overall randomized number of participants is not adequate. The
number of participants randomized to each intervention should be
provided.
Yes No
64

Appendix B - Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomized Controlled Trials in Journal Abstracts – Modified
Checklist (25 Questions)
Item
**
Description Q# In the RCT abstract being assessed, did the authors
Numbers
Analyzed
Number of participants
analyzed in each group
15. report the number of participants included in the analysis for each
intervention?
Note: Overall analyzed number of participants is not adequate. The
number of participants analyzed in each intervention should be
provided.
Yes No
Outcome For the primary outcome,
a result for each group
and the estimated effect
size and its precision
16. for the primary outcome, report trial results as a summary of the
outcome in each group (e.g., the number of participants with or without
the event, or the mean and standard deviation of measurements)?
Yes No
17. for the primary outcome, report the contrast between groups known as
the effect size? For binary outcomes, the effect size could be the relative
risk, relative risk reduction, odds ratio, or risk difference. For survival time
data, the measurement could be the hazard ratio or difference in
median survival time. For continuous data, the effect measure is usually
the difference in means.
Yes No
18. for the primary outcome, present the confidence intervals for the
contrast between groups and as a measure of the precision
(uncertainty) of the estimate of the effect?
Yes No
Harms Important adverse events
or side effects
19. describe any important adverse (or unexpected) effects of an
intervention in the abstract? If no important adverse events have
occurred, did the authors state this explicitly?
Yes No
Conclusions General interpretation of
the results
20. clearly state the conclusions of the trial, consistent with the results
reported in the abstract, along with their clinical application (avoiding
over-generalization) balancing the benefits and harms in their
conclusions. ? Where applicable, authors should also note whether
additional studies are required before the results are used in clinical
settings.
Yes No
Trial Registration Registration number and
name of trial register
21. provide details of the trial registration number? Yes No
22. provide details of the name of trial register? Yes No
Funding Source of funding 23. report the source of funding for the trial? Yes No
Additional useful data Structured abstract
***
24. reports the abstract in traditional structure with subtitles
(Introduction/background, materials/methods, results, conclusion)
Yes No
Statistical significance 25. report 'statistical' significance with or without a ‘p’ value Yes No

Reference: Hopewell S, et al; CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation
and elaboration. PLoS Med. 2008 Jan 22;5(1):e20.
65

Appendix C - Medline Subject Heading (MeSH) ‘Periodontal Diseases’
Pathological processes involving the PERIODONTIUM including the gum (GINGIVA), the alveolar bone
(ALVEOLAR PROCESS), the DENTAL CEMENTUM, and the PERIODONTAL LIGAMENT.

Year introduced: 1965

Subheadings:
analysis
anatomy and histology
blood
blood supply
cerebrospinal fluid
chemically induced
chemistry
classification
complications
congenital
cytology
diagnosis
diet therapy
drug effects
drug therapy
economics
embryology
enzymology
epidemiology
ethnology
etiology
genetics
history
immunology
injuries
instrumentation
metabolism
microbiology
mortality
nursing
organization and administration
parasitology
pathology
physiology
physiopathology
prevention and control
psychology
radiography
radionuclide imaging
radiotherapy
rehabilitation
secondary
statistics and numerical data
surgery
therapy
transmission
ultrasonography
ultrastructure
urine
veterinary
virology

66

Appendix C - Medline Subject Heading (MeSH) ‘Periodontal Diseases’
Tree Number(s): C07.465.714
Entry Terms:
Disease, Periodontal
Diseases, Periodontal
Periodontal Disease
Parodontosis
Parodontoses
Pyorrhea Alveolaris

All MeSH Categories
Diseases Category
Stomatognathic Diseases
Mouth Diseases
Periodontal Diseases
Furcation Defects
Gingival Diseases
Gingival Hemorrhage
Gingival Neoplasms
Gingival Overgrowth +
Gingival Recession
Gingivitis +
Granuloma, Giant Cell
Pericoronitis
Peri-Implantitis
Periapical Diseases
Periapical Periodontitis +
Radicular Cyst
Periodontal Atrophy
Alveolar Bone Loss
Gingival Recession
Periodontal Attachment Loss
Periodontal Cyst
Periodontitis
Aggressive Periodontitis
Chronic Periodontitis
Periapical Periodontitis +
Periodontal Abscess
Periodontal Pocket
Tooth Loss
Tooth Migration
Mesial Movement of Teeth
Tooth Mobility

+ Denotes the term is also a MeSH term.
67

Appendix D – Bibliometrics - Journal and Abstract Metrics
Journal Metric Journal Name of the journal
2013 5-Year Impact Factor From Journal Citation Reports Database*
2013 Eigenfactor® Score From Journal Citation Reports Database
2013 Article Influence® Score From Journal Citation Reports Database
Abstract Metric Word Count Total number of words in the abstract excluding the
title, authors, affiliations and journal details
Number of authors Number of authors in the abstract
Continent Continent of corresponding author
Country Country of corresponding author

Journal Impact Factor*
‘The journal Impact Factor is the average number of times articles from the journal published in the
past two years have been cited in the JCR year. The Impact Factor is calculated by dividing the
number of citations in the JCR year by the total number of articles published in the two previous
years. An Impact Factor of 1.0 means that, on average, the articles published one or two year ago
have been cited one time. An Impact Factor of 2.5 means that, on average, the articles published
one or two year ago have been cited two and a half times. The citing works may be articles
published in the same journal. However, most citing works are from different journals, proceedings,
or books indexed by Web of Science.’
5-Year Journal Impact Factor*
‘The 5-year journal Impact Factor is the average number of times articles from the journal published
in the past five years have been cited in the JCR year. It is calculated by dividing the number of
citations in the JCR year by the total number of articles published in the five previous years.’
Eigenfactor Score* (www.eigenfactor.org)
‘The Eigenfactor Score calculation is based on the number of times articles from the journal
published in the past five years have been cited in the JCR year, but it also considers which journals
have contributed these citations so that highly cited journals will influence the network more than
lesser cited journals. References from one article in a journal to another article from the same
journal are removed, so that Eigenfactor Scores are not influenced by journal self-citation.’
Article Influence Score* (www.eigenfactor.org)
‘The Article Influence determines the average influence of a journal's articles over the first five years
after publication. It is calculated by dividing a journal’s Eigenfactor Score by the number of
articles in the journal, normalized as a fraction of all articles in all publications. This measure is
roughly analogous to the 5-Year Journal Impact Factor in that it is a ratio of a journal’s citation
influence to the size of the journal’s article contribution over a period of five years. The mean
Article Influence Score is 1.00. A score greater than 1.00 indicates that each article in the journal
has above-average influence. A score less than 1.00 indicates that each article in the journal has
below-average influence.’
Note: Eigenfactor
®
Metrics, Eigenfactor
®
Score, Article Influence
®
Score are Licensed Marks used with
permission from the University of Washington. The Eigenfactor
®
Algorithm-2008, was developed by the
Metrics Eigenfactor
®
Project: a bibliometric research project conducted by Professor Carl Bergstrom and his
laboratory at University of Washington.
* Journal Citation Reports
®
, Web of Science
TM
database accessed through University of Southern California
Libraries. http://wokinfo.com/products_tools/analytical/jcr/
68

Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
1. Abrahamsson, P., Walivaara, D.A., Isaksson, S., and Andersson, G. (2012). Periosteal expansion
before local bone reconstruction using a new technique for measuring soft tissue profile stability: a
clinical study. Journal of oral and maxillofacial surgery: official journal of the American Association
of Oral and Maxillofacial Surgeons 70, e521-530.
2. Agado, B.E., Crawford, B., DeLaRosa, J., Bowen, D.M., Peterson, T., Neill, K., and Paarmann, C.
(2012). Effects of periodontal instrumentation on quality of life and illness in patients with chronic
obstructive pulmonary disease: a pilot study. Journal of dental hygiene : JDH / American Dental
Hygienists' Association 86, 204-214.
3. Agarwal, A., and Gupta, N.D. (2012). Comparative evaluation of decalcified freeze-dried bone
allograft use alone and in combination with polylactic acid, polyglycolic acid membrane in the
treatment of noncontained human periodontal infrabony defects. Quintessence international 43,
761-768.
4. Agarwal, E., Pradeep, A.R., Bajaj, P., and Naik, S.B. (2012). Efficacy of local drug delivery of 0.5%
clarithromycin gel as an adjunct to non-surgical periodontal therapy in the treatment of current
smokers with chronic periodontitis: a randomized controlled clinical trial. Journal of periodontology
83, 1155-1163.
5. Aghazadeh, A., Rutger Persson, G., and Renvert, S. (2012). A single-centre randomized controlled
clinical trial on the adjunct treatment of intra-bony defects with autogenous bone or a xenograft:
results after 12 months. Journal of clinical periodontology 39, 666-673.
6. Aimetti, M., Romano, F., Guzzi, N., and Carnevale, G. (2012). Full-mouth disinfection and systemic
antimicrobial therapy in generalized aggressive periodontitis: a randomized, placebo-controlled
trial. Journal of clinical periodontology 39, 284-294.
7. Almeida, G., Marques, E., De Martin, A.S., da Silveira Bueno, C.E., Nowakowski, A., and Cunha, R.S.
(2012). Influence of irrigating solution on postoperative pain following single-visit endodontic
treatment: randomized clinical trial. Journal (Canadian Dental Association) 78, c84.
8. Alves, L.B., Costa, P.P., Scombatti de Souza, S.L., de Moraes Grisi, M.F., Palioto, D.B., Taba Jr, M., and
Novaes Jr, A.B., Jr. (2012). Acellular dermal matrix graft with or without enamel matrix derivative for
root coverage in smokers: a randomized clinical study. Journal of clinical periodontology 39,
393-399.
9. Arnhart, C., Kielbassa, A.M., Martinez-de Fuentes, R., Goldstein, M., Jackowski, J., Lorenzoni, M.,
Maiorana, C., Mericske-Stern, R., Pozzi, A., Rompen, E., et al. (2012). Comparison of variable-thread
tapered implant designs to a standard tapered implant design after immediate loading. A 3-year
multicentre randomised controlled trial. European journal of oral implantology 5, 123-136.
10. Ayad, F., Petrone, D.M., Wachs, G.N., Mateo, L.R., Chaknis, P., and Panagakos, F. (2012).
Comparative efficacy of a specially engineered sonic powered toothbrush with unique sensing and
control technologies to two commercially available power toothbrushes on established plaque and
gingivitis. The Journal of clinical dentistry 23 Spec No A, A5-10.
11. Ayub, L.G., Ramos, U.D., Reino, D.M., Grisi, M.F., Taba, M., Jr., Souza, S.L., Palioto, D.B., and Novaes,
A.B., Jr. (2012). A Randomized comparative clinical study of two surgical procedures to improve root
coverage with the acellular dermal matrix graft. Journal of clinical periodontology 39, 871-878.
12. Badran, Z., Boutigny, H., Struillou, X., Weiss, P., Laboux, O., and Soueidan, A. (2012). Clinical
outcomes after nonsurgical periodontal therapy with an Er:YAG laser device: a randomized
controlled pilot study. Photomedicine and laser surgery 30, 347-353.
13. Baghele, O.N., and Pol, D.G. (2012). An evaluation of the effectiveness and predictability of
69

Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
transpositional flap vs connective tissue graft for coverage of Miller's class-I and class-II facial
marginal tissue recession lesions: a clinical study. Indian journal of dental research : official
publication of Indian Society for Dental Research 23, 195-202.
14. Bajaj, P., Pradeep, A.R., Agarwal, E., Kumari, M., and Naik, S.B. (2012). Locally delivered 0.5%
clarithromycin, as an adjunct to nonsurgical treatment in chronic periodontitis with well-controlled
type 2 diabetes: a randomized controlled clinical trial. Journal of investigative and clinical dentistry
3, 276-283.
15. Balusubramanya, K.V., Ramya, R., and Govindaraj, S.J. (2012). Clinical and radiological evaluation
of human osseous defects (mandibular grade ii furcation involvement) treated with bioresorbable
membrane: vicryl mesh. The journal of contemporary dental practice 13, 806-811.
16. Baqain, Z.H., Al-Shafii, A., Hamdan, A.A., and Sawair, F.A. (2012). Flap design and mandibular third
molar surgery: a split mouth randomized clinical study. International journal of oral and maxillofacial
surgery 41, 1020-1024.
17. Barewal, R.M., Stanford, C., and Weesner, T.C. (2012). A randomized controlled clinical trial
comparing the effects of three loading protocols on dental implant stability. The International
journal of oral & maxillofacial implants 27, 945-956.
18. Barone, A., Orlando, B., Cingano, L., Marconcini, S., Derchi, G., and Covani, U. (2012). A randomized
clinical trial to evaluate and compare implants placed in augmented versus non-augmented
extraction sockets: 3-year results. Journal of periodontology 83, 836-846.
19. Basegmez, C., Ersanli, S., Demirel, K., Bolukbasi, N., and Yalcin, S. (2012). The comparison of two
techniques to increase the amount of peri-implant attached mucosa: free gingival grafts versus
vestibuloplasty. One-year results from a randomised controlled trial. European journal of oral
implantology 5, 139-145.
20. Belal, M.H., Watanabe, H., Ichinose, S., and Ishikawa, I. (2012). Effect of PDGF-BB combined with
EDTA gel on adhesion and proliferation to the root surface. Odontology / the Society of the Nippon
Dental University 100, 206-214.
21. Beus, C., Safavi, K., Stratton, J., and Kaufman, B. (2012). Comparison of the effect of two endodontic
irrigation protocols on the elimination of bacteria from root canal system: a prospective,
randomized clinical trial. Journal of endodontics 38, 1479-1483.
22. Bittencourt, S., Del Peloso Ribeiro, E., Sallum, E.A., Nociti, F.H., Jr., and Casati, M.Z. (2012). Surgical
microscope may enhance root coverage with subepithelial connective tissue graft: a
randomized-controlled clinical trial. Journal of periodontology 83, 721-730.
23. Bokhari, S.A., Khan, A.A., Butt, A.K., Azhar, M., Hanif, M., Izhar, M., and Tatakis, D.N. (2012).
Non-surgical periodontal therapy reduces coronary heart disease risk markers: a randomized
controlled trial. Journal of clinical periodontology 39, 1065-1074.
24. Brownfield, L.A., and Weltman, R.L. (2012). Ridge preservation with or without an osteoinductive
allograft: a clinical, radiographic, micro-computed tomography, and histologic study evaluating
dimensional changes and new bone formation of the alveolar ridge. Journal of periodontology 83,
581-589.
25. Cairo, F., Cortellini, P., Tonetti, M., Nieri, M., Mervelt, J., Cincinelli, S., and Pini-Prato, G. (2012).
Coronally advanced flap with and without connective tissue graft for the treatment of single
maxillary gingival recession with loss of inter-dental attachment. A randomized controlled clinical
trial. Journal of clinical periodontology 39, 760-768.
26. Cannizzaro, G., Felice, P., Leone, M., Ferri, V., Viola, P., and Esposito, M. (2012). Immediate versus
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Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
early loading of 6.5 mm-long flapless-placed single implants: a 4-year after loading report of a
split-mouth randomised controlled trial. European journal of oral implantology 5, 111-121.
27. Cannizzaro, G., Leone, M., Ferri, V., Viola, P., Gelpi, F., and Esposito, M. (2012). Immediate loading of
single implants inserted flapless with medium or high insertion torque: a 6-month follow-up of a
split-mouth randomised controlled trial. European journal of oral implantology 5, 333-342.
28. Canullo, L., Iannello, G., Netuschil, L., and Jepsen, S. (2012). Platform switching and matrix
metalloproteinase-8 levels in peri-implant sulcular fluid. Clinical oral implants research 23, 556-559.
29. Canullo, L., Iannello, G., Penarocha, M., and Garcia, B. (2012). Impact of implant diameter on bone
level changes around platform switched implants: preliminary results of 18 months follow-up a
prospective randomized match-paired controlled trial. Clinical oral implants research 23, 1142-1146.
30. Canullo, L., Rosa, J.C., Pinto, V.S., Francischone, C.E., and Gotz, W. (2012). Inward-inclined implant
platform for the amplified platform-switching concept: 18-month follow-up report of a prospective
randomized matched-pair controlled trial. The International journal of oral & maxillofacial implants
27, 927-934.
31. Cappuyns, I., Cionca, N., Wick, P., Giannopoulou, C., and Mombelli, A. (2012). Treatment of residual
pockets with photodynamic therapy, diode laser, or deep scaling. A randomized, split-mouth
controlled clinical trial. Lasers in medical science 27, 979-986.
32. Cardaropoli, D., Tamagnone, L., Roffredo, A., and Gaveglio, L. (2012). Treatment of gingival
recession defects using coronally advanced flap with a porcine collagen matrix compared to
coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. Journal
of periodontology 83, 321-328.
33. Cardaropoli, D., Tamagnone, L., Roffredo, A., Gaveglio, L., and Cardaropoli, G. (2012). Socket
preservation using bovine bone mineral and collagen membrane: a randomized controlled clinical
trial with histologic analysis. The International journal of periodontics & restorative dentistry 32,
421-430.
34. Carney, C.M., Rossmann, J.A., Kerns, D.G., Cipher, D.J., Rees, T.D., Solomon, E.S., Rivera-Hidalgo, F.,
and Beach, M.M. (2012). A comparative study of root defect coverage using an acellular dermal
matrix with and without a recombinant human platelet-derived growth factor. Journal of
periodontology 83, 893-901.
35. Casarin, R.C., Peloso Ribeiro, E.D., Sallum, E.A., Nociti, F.H., Jr., Goncalves, R.B., and Casati, M.Z.
(2012). The combination of amoxicillin and metronidazole improves clinical and microbiologic
results of one-stage, full-mouth, ultrasonic debridement in aggressive periodontitis treatment.
Journal of periodontology 83, 988-998.
36. Chandra, R.V., Sandhya, Y.P., Nagarajan, S., Reddy, B.H., Naveen, A., and Murthy, K.R. (2012).
Efficacy of lycopene as a locally delivered gel in the treatment of chronic periodontitis: smokers vs
nonsmokers. Quintessence international 43, 401-411.
37. Chapple, I.L., Milward, M.R., Ling-Mountford, N., Weston, P., Carter, K., Askey, K., Dallal, G.E., De Spirt,
S., Sies, H., Patel, D., et al. (2012). Adjunctive daily supplementation with encapsulated fruit,
vegetable and berry juice powder concentrates and clinical periodontal outcomes: a double-blind
RCT. Journal of clinical periodontology 39, 62-72.
38. Charles, C.A., Amini, P., Gallob, J., Shang, H., McGuire, J.A., and Costa, R. (2012). Antiplaque and
antigingivitis efficacy of an alcohol-free essential-oil containing mouthrinse: a 2-week clinical trial.
American journal of dentistry 25, 195-198.
39. Chen, L., Luo, G., Xuan, D., Wei, B., Liu, F., Li, J., and Zhang, J. (2012). Effects of non-surgical
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Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
periodontal treatment on clinical response, serum inflammatory parameters, and metabolic control
in patients with type 2 diabetes: a randomized study. Journal of periodontology 83, 435-443.
40. Cirano, F.R., Pera, C., Ueda, P., Casarin, R.C., Ribeiro, F.V., Pimentel, S.P., and Casati, M.Z. (2012).
Clinical and metabolic evaluation of one-stage, full-mouth, ultrasonic debridement as a
therapeutic approach for uncontrolled type 2 diabetic patients with periodontitis. Quintessence
international 43, 671-681.
41. Cordaro, L., di Torresanto, V.M., and Torsello, F. (2012). Split-mouth comparison of a coronally
advanced flap with or without enamel matrix derivative for coverage of multiple gingival recession
defects: 6- and 24-month follow-up. The International journal of periodontics & restorative dentistry
32, e10-20.
42. Cortelli, J.R., Cogo, K., Aquino, D.R., Cortelli, S.C., Ricci-Nittel, D., Zhang, P., and Araujo, M.W. (2012).
Validation of the anti-bacteremic efficacy of an essential oil rinse in a Brazilian population: a
cross-over study. Brazilian oral research 26, 478-484.
43. Cortelli, S.C., Cortelli, J.R., Wu, M.M., Simmons, K., and Charles, C.A. (2012). Comparative antiplaque
and antigingivitis efficacy of a multipurpose essential oil-containing mouthrinse and a
cetylpyridinium chloride-containing mouthrinse: A 6-month randomized clinical trial. Quintessence
international 43, e82-94.
44. Crespi, R., Vinci, R., Cappare, P., Romanos, G.E., and Gherlone, E. (2012). A clinical study of
edentulous patients rehabilitated according to the "all on four" immediate function protocol. The
International journal of oral & maxillofacial implants 27, 428-434.
45. De Angelis, N., Felice, P., Grusovin, M.G., Camurati, A., and Esposito, M. (2012). The effectiveness of
adjunctive light-activated disinfection (LAD) in the treatment of peri-implantitis: 4-month results from
a multicentre pragmatic randomised controlled trial. European journal of oral implantology 5,
321-331.
46. de Lima Oliveira, A.P., de Faveri, M., Gursky, L.C., Mestnik, M.J., Feres, M., Haffajee, A.D., Socransky,
S.S., and Teles, R.P. (2012). Effects of periodontal therapy on GCF cytokines in generalized
aggressive periodontitis subjects. Journal of clinical periodontology 39, 295-302.
47. De Nardo, R., Chiappe, V., Gomez, M., Romanelli, H., and Slots, J. (2012). Effects of 0.05% sodium
hypochlorite oral rinse on supragingival biofilm and gingival inflammation. International dental
journal 62, 208-212.
48. Degidi, M., Artese, L., Piattelli, A., Scarano, A., Shibli, J.A., Piccirilli, M., Perrotti, V., and Iezzi, G. (2012).
Histological and immunohistochemical evaluation of the peri-implant soft tissues around machined
and acid-etched titanium healing abutments: a prospective randomised study. Clinical oral
investigations 16, 857-866.
49. Del Fabbro, M., Ceresoli, V., Lolato, A., and Taschieri, S. (2012). Effect of platelet concentrate on
quality of life after periradicular surgery: a randomized clinical study. Journal of endodontics 38,
733-739.
50. Elsyad, M.A., Al-Mahdy, Y.F., and Fouad, M.M. (2012). Marginal bone loss adjacent to conventional
and immediate loaded two implants supporting a ball-retained mandibular overdenture: a 3-year
randomized clinical trial. Clinical oral implants research 23, 496-503.
51. Eltas, A., and Orbak, R. (2012). Clinical effects of Nd:YAG laser applications during nonsurgical
periodontal treatment in smoking and nonsmoking patients with chronic periodontitis.
Photomedicine and laser surgery 30, 360-366.
52. Eltas, A., and Orbak, R. (2012). Effect of 1,064-nm Nd:YAG laser therapy on GCF IL-1beta and MMP-8
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levels in patients with chronic periodontitis. Lasers in medical science 27, 543-550.
53. Emingil, G., Han, B., Ozdemir, G., Tervahartiala, T., Vural, C., Atilla, G., Baylas, H., and Sorsa, T. (2012).
Effect of azithromycin, as an adjunct to nonsurgical periodontal treatment, on microbiological
parameters and gingival crevicular fluid biomarkers in generalized aggressive periodontitis. Journal
of periodontal research 47, 729-739.
54. Esposito, M., Grusovin, M.G., Pellegrino, G., Soardi, E., and Felice, P. (2012). Safety and effectiveness
of maxillary early loaded titanium implants with a novel nanostructured calcium-incorporated
surface (Xpeed): 1-year results from a pilot multicenter randomised controlled trial. European journal
of oral implantology 5, 241-249.
55. Fawzy El-Sayed, K.M., Dahaba, M.A., Aboul-Ela, S., and Darhous, M.S. (2012). Local application of
hyaluronan gel in conjunction with periodontal surgery: a randomized controlled trial. Clinical oral
investigations 16, 1229-1236.
56. Felice, P., Pistilli, R., Piattelli, M., Soardi, E., Corvino, V., and Esposito, M. (2012). Posterior atrophic jaws
rehabilitated with prostheses supported by 5 x 5 mm implants with a novel nanostructured
calcium-incorporated titanium surface or by longer implants in augmented bone. Preliminary results
from a randomised controlled trial. European journal of oral implantology 5, 149-161.
57. Feres, M., Soares, G.M., Mendes, J.A., Silva, M.P., Faveri, M., Teles, R., Socransky, S.S., and Figueiredo,
L.C. (2012). Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic
periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. Journal of
clinical periodontology 39, 1149-1158.
58. Fernandez-Formoso, N., Rilo, B., Mora, M.J., Martinez-Silva, I., and Diaz-Afonso, A.M. (2012).
Radiographic evaluation of marginal bone maintenance around tissue level implant and bone
level implant: a randomised controlled trial. A 1-year follow-up. Journal of oral rehabilitation 39,
830-837.
59. Filipek, D., Koszowski, R., and Smieszek-Wilczewska, J. (2012). A comparative clinical study on human
tooth extractions: flap vs flapless buccal surgery. Quintessence international 43, 887-889.
60. Flemmig, T.F., Arushanov, D., Daubert, D., Rothen, M., Mueller, G., and Leroux, B.G. (2012).
Randomized controlled trial assessing efficacy and safety of glycine powder air polishing in
moderate-to-deep periodontal pockets. Journal of periodontology 83, 444-452.
61. Funosas, E., Feser, G., Escovich, L., and Maestri, L. (2012). Alteration of hemostasis in patients treated
with subgingival NSAIDs during periodontal therapy. Acta odontologica latinoamericana : AOL 25,
103-108.
62. Gadallah, A.A., Youssef, H.G., and Shawky, Y.M. (2012). A comparative study between early
occlusal loading at 1 and 6 weeks in implant-retained mandibular overdentures. Implant dentistry
21, 242-247.
63. Gamal, A.Y., and Kumper, R.M. (2012). A novel approach to the use of doxycycline-loaded
biodegradable membrane and EDTA root surface etching in chronic periodontitis: a randomized
clinical trial. Journal of periodontology 83, 1086-1094.
64. Ganesh, M., Shah, S., Parikh, D., Choudhary, P., and Bhaskar, V. (2012). The effectiveness of a
musical toothbrush for dental plaque removal: a comparative study. Journal of the Indian Society of
Pedodontics and Preventive Dentistry 30, 139-145.
65. Genovesi, A.M., Ricci, M., Marchisio, O., and Covani, U. (2012). Periodontal dressing may influence
the clinical outcome of non-surgical periodontal treatment: a split-mouth study. International journal
of dental hygiene 10, 284-289.
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Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
66. Gerlach, R.W., and Amini, P. (2012). Randomized controlled trial of 0.454% stannous fluoride
dentifrice to treat gingival bleeding. Compendium of continuing education in dentistry 33, 134-136,
138.
67. Giannelli, M., Formigli, L., Lorenzini, L., and Bani, D. (2012). Combined photoablative and
photodynamic diode laser therapy as an adjunct to non-surgical periodontal treatment: a
randomized split-mouth clinical trial. Journal of clinical periodontology 39, 962-970.
68. Giannopoulou, C., Cappuyns, I., Cancela, J., Cionca, N., and Mombelli, A. (2012). Effect of
photodynamic therapy, diode laser, and deep scaling on cytokine and acute-phase protein levels
in gingival crevicular fluid of residual periodontal pockets. Journal of periodontology 83, 1018-1027.
69. Gilowski, L., Kondzielnik, P., Wiench, R., Plocica, I., Strojek, K., and Krzeminski, T.F. (2012). Efficacy of
short-term adjunctive subantimicrobial dose doxycycline in diabetic patients--randomized study.
Oral diseases 18, 763-770.
70. Goldsmith, S.M., De Silva, R.K., Tong, D.C., and Love, R.M. (2012). Influence of a pedicle flap design
on acute postoperative sequelae after lower third molar removal. International journal of oral and
maxillofacial surgery 41, 371-375.
71. Gondim, J.O., Avaca-Crusca, J.S., Valentini, S.R., Zanelli, C.F., Spolidorio, D.M., and Giro, E.M. (2012).
Effect of a calcium hydroxide/chlorhexidine paste as intracanal dressing in human primary teeth
with necrotic pulp against Porphyromonas gingivalis and Enterococcus faecalis. International
journal of paediatric dentistry / the British Paedodontic Society [and] the International Association of
Dentistry for Children 22, 116-124.
72. Goodson, J.M., Haffajee, A.D., Socransky, S.S., Kent, R., Teles, R., Hasturk, H., Bogren, A., Van Dyke, T.,
Wennstrom, J., and Lindhe, J. (2012). Control of periodontal infections: a randomized controlled trial
I. The primary outcome attachment gain and pocket depth reduction at treated sites. Journal of
clinical periodontology 39, 526-536.
73. Goyal, C.R., Klukowska, M., Grender, J.M., Cunningham, P., and Qaqish, J. (2012). Evaluation of a
new multi-directional power toothbrush versus a marketed sonic toothbrush on plaque and gingivitis
efficacy. American journal of dentistry 25 Spec No A, 21A-26A.
74. Goyal, C.R., Lyle, D.M., Qaqish, J.G., and Schuller, R. (2012). The addition of a water flosser to power
tooth brushing: effect on bleeding, gingivitis, and plaque. The Journal of clinical dentistry 23, 57-63.
75. Grandi, T., Garuti, G., Guazzi, P., Tarabini, L., and Forabosco, A. (2012). Survival and success rates of
immediately and early loaded implants: 12-month results from a multicentric randomized clinical
study. The Journal of oral implantology 38, 239-249.
76. Grandi, T., Guazzi, P., Samarani, R., and Garuti, G. (2012). Immediate positioning of definitive
abutments versus repeated abutment replacements in immediately loaded implants: effects on
bone healing at the 1-year follow-up of a multicentre randomised controlled trial. European journal
of oral implantology 5, 9-16.
77. Gultekin, S.E., Senguven, B., Sofuoglu, A., Taner, L., and Koch, M. (2012). Effect of the topical use of
the antioxidant taurine on the two basement membrane proteins of regenerating oral gingival
epithelium. Journal of periodontology 83, 127-134.
78. Haas, A.N., Seleme, F., Segatto, P., Susin, C., Albandar, J., Oppermann, R.V., Fontanella, V.R., and
Rosing, C.K. (2012). Azithromycin as an adjunctive treatment of aggressive periodontitis:
radiographic findings of a 12-month randomized clinical trial. American journal of dentistry 25,
215-219.
79. Haas, A.N., Silva-Boghossian, C.M., Colombo, A.P., Susin, C., Albandar, J.M., Oppermann, R.V., and
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Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
Rosing, C.K. (2012). Adjunctive azithromycin in the treatment of aggressive periodontitis:
microbiological findings of a 12-month randomized clinical trial. Journal of dentistry 40, 556-563.
80. Hallstrom, H., Persson, G.R., Lindgren, S., Olofsson, M., and Renvert, S. (2012). Systemic antibiotics and
debridement of peri-implant mucositis. A randomized clinical trial. Journal of clinical periodontology
39, 574-581.
81. Hammerle, C.H., Jung, R.E., Sanz, M., Chen, S., Martin, W.C., and Jackowski, J. (2012). Submerged
and transmucosal healing yield the same clinical outcomes with two-piece implants in the anterior
maxilla and mandible: interim 1-year results of a randomized, controlled clinical trial. Clinical oral
implants research 23, 211-219.
82. Han, B., Emingil, G., Ozdemir, G., Tervahartiala, T., Vural, C., Atilla, G., Baylas, H., and Sorsa, T. (2012).
Azithromycin as an adjunctive treatment of generalized severe chronic periodontitis: clinical,
microbiologic, and biochemical parameters. Journal of periodontology 83, 1480-1491.
83. Harnacke, D., Mitter, S., Lehner, M., Munzert, J., and Deinzer, R. (2012). Improving oral hygiene skills
by computer-based training: a randomized controlled comparison of the modified Bass and the
Fones techniques. PloS one 7, e37072.
84. Harper, L.M., Parry, S., Stamilio, D.M., Odibo, A.O., Cahill, A.G., Strauss, J.F., 3rd, and Macones, G.A.
(2012). The interaction effect of bacterial vaginosis and periodontal disease on the risk of preterm
delivery. American journal of perinatology 29, 347-352.
85. Hart, R., Doherty, D.A., Pennell, C.E., Newnham, I.A., and Newnham, J.P. (2012). Periodontal disease:
a potential modifiable risk factor limiting conception. Human reproduction (Oxford, England) 27,
1332-1342.
86. Hashemi, H.M., Beshkar, M., and Aghajani, R. (2012). The effect of sutureless wound closure on
postoperative pain and swelling after impacted mandibular third molar surgery. The British journal of
oral & maxillofacial surgery 50, 256-258.
87. Hassan, K.S., Marei, H.F., and Alagl, A.S. (2012). Does grafting of third molar extraction sockets
enhance periodontal measures in 30- to 35-year-old patients? Journal of oral and maxillofacial
surgery : official journal of the American Association of Oral and Maxillofacial Surgeons 70, 757-764.
88. He, T., Barker, M.L., Biesbock, A.R., Sharma, N.C., Qaqish, J., and Goyal, C.R. (2012). Assessment of
the effects of a stannous fluoride dentifrice on gingivitis in a two-month positive-controlled clinical
study. The Journal of clinical dentistry 23, 80-85.
89. He, T., Barker, M.L., Goyal, C.R., and Biesbrock, A.R. (2012). Anti-gingivitis effects of a novel 0.454%
stabilized stannous fluoride dentifrice relative to a positive control. American journal of dentistry 25,
136-140.
90. Hebbal, M., Ankola, A.V., Sharma, R., and Johri, S. (2012). Effectiveness of herbal and fluoridated
toothpaste on plaque and gingival scores among residents of a working women's hostel - a
randomised controlled trial. Oral health & preventive dentistry 10, 389-395.
91. Hoang, T.N., and Mealey, B.L. (2012). Histologic comparison of healing after ridge preservation using
human demineralized bone matrix putty with one versus two different-sized bone particles. Journal
of periodontology 83, 174-181.
92. Iniesta, M., Herrera, D., Montero, E., Zurbriggen, M., Matos, A.R., Marin, M.J., Sanchez-Beltran, M.C.,
Llama-Palacio, A., and Sanz, M. (2012). Probiotic effects of orally administered Lactobacillus
reuteri-containing tablets on the subgingival and salivary microbiota in patients with gingivitis. A
randomized clinical trial. Journal of clinical periodontology 39, 736-744.
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Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
93. Ishihata, K., Wakabayashi, N., Wadachi, J., Akizuki, T., Izumi, Y., Takakuda, K., and Igarashi, Y. (2012).
Reproducibility of probing depth measurement by an experimental periodontal probe
incorporating optical fiber sensor. Journal of periodontology 83, 222-227.
94. Jadhav, G., Shah, N., and Logani, A. (2012). Revascularization with and without platelet-rich plasma
in nonvital, immature, anterior teeth: a pilot clinical study. Journal of endodontics 38, 1581-1587.
95. Jain, N., Lai, P.C., and Walters, J.D. (2012). Effect of gingivitis on azithromycin concentrations in
gingival crevicular fluid. Journal of periodontology 83, 1122-1128.
96. Jankovic, S., Aleksic, Z., Klokkevold, P., Lekovic, V., Dimitrijevic, B., Kenney, E.B., and Camargo, P.
(2012). Use of platelet-rich fibrin membrane following treatment of gingival recession: a randomized
clinical trial. The International journal of periodontics & restorative dentistry 32, e41-50.
97. Jaya, A.R., Praveen, P., Anantharaj, A., Venkataraghavan, K., and Rani, P.S. (2012). In vivo
evaluation of lesion sterilization and tissue repair in primary teeth pulp therapy using two antibiotic
drug combinations. The Journal of clinical pediatric dentistry 37, 189-191.
98. Jonsson, B., Baker, S.R., Lindberg, P., Oscarson, N., and Ohrn, K. (2012). Factors influencing oral
hygiene behaviour and gingival outcomes 3 and 12 months after initial periodontal treatment: an
exploratory test of an extended Theory of Reasoned Action. Journal of clinical periodontology 39,
138-144.
99. Jonsson, B., Ohrn, K., Lindberg, P., and Oscarson, N. (2012). Cost-effectiveness of an individually
tailored oral health educational programme based on cognitive behavioural strategies in
non-surgical periodontal treatment. Journal of clinical periodontology 39, 659-665.
100. Junemann, S., Prior, K., Szczepanowski, R., Harks, I., Ehmke, B., Goesmann, A., Stoye, J., and Harmsen,
D. (2012). Bacterial community shift in treated periodontitis patients revealed by ion torrent 16S rRNA
gene amplicon sequencing. PloS one 7, e41606.
101. Jung, D.Y., Park, J.C., Kim, Y.T., Yon, J.Y., Im, G.I., Kim, B.S., Choi, S.H., Cho, K.S., and Kim, C.S. (2012).
The clinical effect of locally delivered minocycline in association with flap surgery for the treatment
of chronic severe periodontitis: a split-mouth design. Journal of clinical periodontology 39, 753-759.
102. Klukowska, M., Grender, J.M., Goyal, C.R., Mandl, C., and Biesbrock, A.R. (2012). 12-week clinical
evaluation of a rotation/oscillation power toothbrush versus a new sonic power toothbrush in
reducing gingivitis and plaque. American journal of dentistry 25, 287-292.
103. Klukowska, M., Grender, J.M., Goyal, C.R., Qaqish, J., and Biesbrock, A.R. (2012). 8-week evaluation
of anti-plaque and anti-gingivitis benefits of a unique multi-directional power toothbrush versus a
sonic control toothbrush. American journal of dentistry 25 Spec No A, 27A-32A.
104. Kocyigit, I.D., Atil, F., Alp, Y.E., Tekin, U., and Tuz, H.H. (2012). Piezosurgery versus conventional surgery
in radicular cyst enucleation. The Journal of craniofacial surgery 23, 1805-1808.
105. Koromantzos, P.A., Makrilakis, K., Dereka, X., Offenbacher, S., Katsilambros, N., Vrotsos, I.A., and
Madianos, P.N. (2012). Effect of non-surgical periodontal therapy on C-reactive protein, oxidative
stress, and matrix metalloproteinase (MMP)-9 and MMP-2 levels in patients with type 2 diabetes: a
randomized controlled study. Journal of periodontology 83, 3-10.
106. Kraivaphan, P., and Amornchat, C. (2012). Effect of an essential oil-containing dentifrice on
established plaque and gingivitis. The Southeast Asian journal of tropical medicine and public
health 43, 243-248.
107. Krohn-Dale, I., Boe, O.E., Enersen, M., and Leknes, K.N. (2012). Er:YAG laser in the treatment of
periodontal sites with recurring chronic inflammation: a 12-month randomized, controlled clinical
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Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
trial. Journal of clinical periodontology 39, 745-752.
108. Kruck, C., Eick, S., Knofler, G.U., Purschwitz, R.E., and Jentsch, H.F. (2012). Clinical and microbiologic
results 12 months after scaling and root planing with different irrigation solutions in patients with
moderate chronic periodontitis: a pilot randomized trial. Journal of periodontology 83, 312-320.
109. Kudva, P., Tabasum, S.T., and Gupta, S. (2012). Comparative evaluation of the efficacy of turmeric
and curcumin as a local drug delivery system: a clinicomicrobiological study. General dentistry 60,
e283-287.
110. Kyriazis, T., Gkrizioti, S., Mikrogeorgis, G., Tsalikis, L., Sakellari, D., Lyroudia, K., and Konstantinides, A.
(2012). Crestal bone resorption after the application of two periodontal surgical techniques: a
randomized, controlled clinical trial. Journal of clinical periodontology 39, 971-978.
111. Lalic, M., Aleksic, E., Gajic, M., Milic, J., and Malesevic, D. (2012). Does oral health counseling
effectively improve oral hygiene of orthodontic patients? European journal of paediatric dentistry :
official journal of European Academy of Paediatric Dentistry 13, 181-186.
112. Lee, A., Ghaname, C.B., Braun, T.M., Sugai, J.V., Teles, R.P., Loesche, W.J., Kornman, K.S., Giannobile,
W.V., and Kinney, J.S. (2012). Bacterial and salivary biomarkers predict the gingival inflammatory
profile. Journal of periodontology 83, 79-89.
113. Lekovic, V., Milinkovic, I., Aleksic, Z., Jankovic, S., Stankovic, P., Kenney, E.B., and Camargo, P.M.
(2012). Platelet-rich fibrin and bovine porous bone mineral vs. platelet-rich fibrin in the treatment of
intrabony periodontal defects. Journal of periodontal research 47, 409-417.
114. Li, Y., Lee, S., Stephens, J., Mateo, L.R., Zhang, Y.P., and DeVizio, W. (2012). Comparison of efficacy of
an arginine-calcium carbonate-MFP toothpaste to a calcium carbonate-MFP toothpaste in
controlling supragingival calculus formation and gingivitis: a 6-month clinical study. American
journal of dentistry 25, 21-25.
115. Lin, S.J., Tu, Y.K., Tsai, S.C., Lai, S.M., and Lu, H.K. (2012). Non-surgical periodontal therapy with and
without subgingival minocycline administration in patients with poorly controlled type II diabetes: a
randomized controlled clinical trial. Clinical oral investigations 16, 599-609.
116. Lindgren, C., Mordenfeld, A., and Hallman, M. (2012). A prospective 1-year clinical and
radiographic study of implants placed after maxillary sinus floor augmentation with synthetic
biphasic calcium phosphate or deproteinized bovine bone. Clinical implant dentistry and related
research 14, 41-50.
117. Llambes, F., Silvestre, F.J., Hernandez-Mijares, A., Guiha, R., Bautista, D., and Caffesse, R. (2012). Efect
of periodontal disease and non surgical periodontal treatment on C-reactive protein. Evaluation of
type 1 diabetic patients. Med Oral Patol Oral Cir Bucal 17, e562-568.
118. Lopez, N.J., Quintero, A., Casanova, P.A., Ibieta, C.I., Baelum, V., and Lopez, R. (2012). Effects of
periodontal therapy on systemic markers of inflammation in patients with metabolic syndrome: a
controlled clinical trial. Journal of periodontology 83, 267-278.
119. Lorenzo, R., Garcia, V., Orsini, M., Martin, C., and Sanz, M. (2012). Clinical efficacy of a xenogeneic
collagen matrix in augmenting keratinized mucosa around implants: a randomized controlled
prospective clinical trial. Clinical oral implants research 23, 316-324.
120. MA, E.L. (2012). Prosthetic aspects and patient satisfaction with resilient liner and clip attachments
for bar- and implant-retained mandibular overdentures: a 3-year randomized clinical study. The
International journal of prosthodontics 25, 148-156.
121. Machtei, E.E., Frankenthal, S., Levi, G., Elimelech, R., Shoshani, E., Rosenfeld, O., Tagger-Green, N.,
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and Shlomi, B. (2012). Treatment of peri-implantitis using multiple applications of chlorhexidine chips:
a double-blind, randomized multi-centre clinical trial. Journal of clinical periodontology 39,
1198-1205.
122. Madlena, M., Banoczy, J., Gotz, G., Marton, S., Kaan, M., Jr., and Nagy, G. (2012). Effects of amine
and stannous fluorides on plaque accumulation and gingival health in orthodontic patients treated
with fixed appliances: a pilot study. Oral health and dental management 11, 57-61.
123. Mahajan, A., Bharadwaj, A., and Mahajan, P. (2012). Comparison of periosteal pedicle graft and
subepithelial connective tissue graft for the treatment of gingival recession defects. Australian
dental journal 57, 51-57.
124. Makhlouf, M., Dahaba, M.M., Tuner, J., Eissa, S.A., and Harhash, T.A. (2012). Effect of adjunctive low
level laser therapy (LLLT) on nonsurgical treatment of chronic periodontitis. Photomedicine and laser
surgery 30, 160-166.
125. Malali, E., Kadir, T., and Noyan, U. (2012). Er:YAG lasers versus ultrasonic and hand instruments in
periodontal therapy: clinical parameters, intracrevicular micro-organism and leukocyte counts.
Photomedicine and laser surgery 30, 543-550.
126. Matula, K., Ramamurthy, R., Bose, C., Goldstein, R., Couper, D., Peralta-Carcelen, M., Stewart, D.,
Gustafson, K.E., and Offenbacher, S. (2012). Effect of antenatal treatment of maternal periodontitis
on early childhood neurodevelopment. American journal of perinatology 29, 815-821.
127. McGuire, M.K., Scheyer, E.T., and Nunn, M. (2012). Evaluation of human recession defects treated
with coronally advanced flaps and either enamel matrix derivative or connective tissue:
comparison of clinical parameters at 10 years. Journal of periodontology 83, 1353-1362.
128. Meloni, S.M., De Riu, G., Pisano, M., De Riu, N., and Tullio, A. (2012). Immediate versus delayed
loading of single mandibular molars. One-year results from a randomised controlled trial. European
journal of oral implantology 5, 345-353.
129. Mendonca, A.C., Santos, V.R., Ribeiro, F.V., Lima, J.A., Miranda, T.S., Feres, M., and Duarte, P.M.
(2012). Surgical and non-surgical therapy with systemic antimicrobials for residual pockets in type 2
diabetics with chronic periodontitis: a pilot study. Journal of clinical periodontology 39, 368-376.
130. Mestnik, M.J., Feres, M., Figueiredo, L.C., Soares, G., Teles, R.P., Fermiano, D., Duarte, P.M., and
Faveri, M. (2012). The effects of adjunctive metronidazole plus amoxicillin in the treatment of
generalized aggressive periodontitis: a 1-year double-blinded, placebo-controlled, randomized
clinical trial. Journal of clinical periodontology 39, 955-961.
131. Miani, P.K., do Nascimento, C., Sato, S., Filho, A.V., da Fonseca, M.J., and Pedrazzi, V. (2012). In vivo
evaluation of a metronidazole-containing gel for the adjuvant treatment of chronic periodontitis:
preliminary results. European journal of clinical microbiology & infectious diseases : official
publication of the European Society of Clinical Microbiology 31, 1611-1618.
132. Moder, D., Taubenhansl, F., Hiller, K.A., Schmalz, G., and Christgau, M. (2012). Influence of
autogenous platelet concentrate on combined GTR/graft therapy in intrabony defects: a 7-year
follow-up of a randomized prospective clinical split-mouth study. Journal of clinical periodontology
39, 457-465.
133. Moeintaghavi, A., Arab, H.R., Bozorgnia, Y., Kianoush, K., and Alizadeh, M. (2012). Non-surgical
periodontal therapy affects metabolic control in diabetics: a randomized controlled clinical trial.
Australian dental journal 57, 31-37.
134. Mohamed, G.F., and El Sawy, A.A. (2012). The role of single immediate loading implant in long Class
IV Kennedy mandibular partial denture. Clinical implant dentistry and related research 14, 708-715.
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135. Mumcu, E., Bilhan, H., and Geckili, O. (2012). The influence of healing type on marginal bone levels
of implants supporting mandibular overdentures: a randomized clinical study. Indian journal of
dental research : official publication of Indian Society for Dental Research 23, 514-518.
136. Munster Halvari, A.E., Halvari, H., Bjornebekk, G., and Deci, E.L. (2012). Self-determined motivational
predictors of increases in dental behaviors, decreases in dental plaque, and improvement in oral
health: a randomized clinical trial. Health psychology : official journal of the Division of Health
Psychology, American Psychological Association 31, 777-788.
137. Nakajima, T., Okui, T., Miyauchi, S., Honda, T., Shimada, Y., Ito, H., Akazawa, K., and Yamazaki, K.
(2012). Effects of systemic sitafloxacin on periodontal infection control in elderly patients.
Gerodontology 29, e1024-1032.
138. Namiranian, H., and Serino, G. (2012). The effect of a toothpaste containing aloe vera on
established gingivitis. Swedish dental journal 36, 179-185.
139. Nathoo, S., Mankodi, S., Mateo, L.R., Chaknis, P., and Panagakos, F. (2012). A clinical study
comparing the supragingival plaque and gingivitis efficacy of a specially engineered sonic
powered toothbrush with unique sensing and control technologies to a commercially available
manual flat-trim toothbrush. The Journal of clinical dentistry 23 Spec No A, A11-16.
140. Nicu, E.A., Van Assche, N., Coucke, W., Teughels, W., and Quirynen, M. (2012). RCT comparing
implants with turned and anodically oxidized surfaces: a pilot study, a 3-year follow-up. Journal of
clinical periodontology 39, 1183-1190.
141. Noro Filho, G.A., Casarin, R.C., Casati, M.Z., and Giovani, E.M. (2012). PDT in non-surgical treatment
of periodontitis in HIV patients: a split-mouth, randomized clinical trial. Lasers in surgery and
medicine 44, 296-302.
142. Novaes, A.B., Jr., Schwartz-Filho, H.O., de Oliveira, R.R., Feres, M., Sato, S., and Figueiredo, L.C.
(2012). Antimicrobial photodynamic therapy in the non-surgical treatment of aggressive
periodontitis: microbiological profile. Lasers in medical science 27, 389-395.
143. Olsson, H., Asklow, B., Johansson, E., and Slotte, C. (2012). Rinsing with alcohol-free or alcohol-based
chlorhexidine solutions after periodontal surgery. A double-blind, randomized, cross-over, pilot
study. Swedish dental journal 36, 91-99.
144. Ortorp, A., and Jemt, T. (2012). CNC-milled titanium frameworks supported by implants in the
edentulous jaw: a 10-year comparative clinical study. Clinical implant dentistry and related
research 14, 88-99.
145. Ozdemir, B., and Okte, E. (2012). Treatment of intrabony defects with beta-tricalciumphosphate
alone and in combination with platelet-rich plasma. Journal of biomedical materials research Part
B, Applied biomaterials 100, 976-983.
146. Papas, A.S., Vollmer, W.M., Gullion, C.M., Bader, J., Laws, R., Fellows, J., Hollis, J.F., Maupome, G.,
Singh, M.L., Snyder, J., et al. (2012). Efficacy of chlorhexidine varnish for the prevention of adult
caries: a randomized trial. Journal of dental research 91, 150-155.
147. Paredes-Vieyra, J., and Enriquez, F.J. (2012). Success rate of single- versus two-visit root canal
treatment of teeth with apical periodontitis: a randomized controlled trial. Journal of endodontics
38, 1164-1169.
148. Parkin, N.A., Deery, C., Smith, A.M., Tinsley, D., Sandler, J., and Benson, P.E. (2012). No difference in
surgical outcomes between open and closed exposure of palatally displaced maxillary canines.
Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and
Maxillofacial Surgeons 70, 2026-2034.
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Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
149. Pasqualini, D., Mollo, L., Scotti, N., Cantatore, G., Castellucci, A., Migliaretti, G., and Berutti, E. (2012).
Postoperative pain after manual and mechanical glide path: a randomized clinical trial. Journal of
endodontics 38, 32-36.
150. Patel, P.V., Kumar, S., Vidya, G.D., Patel, A., Holmes, J.C., and Kumar, V. (2012). Cytological
assessment of healing palatal donor site wounds and grafted gingival wounds after application of
ozonated oil: an eighteen-month randomized controlled clinical trial. Acta cytologica 56, 277-284.
151. Patel, P.V., Patel, A., Kumar, S., and Holmes, J.C. (2012). Effect of subgingival application of topical
ozonated olive oil in the treatment of chronic periodontitis: a randomized, controlled, double blind,
clinical and microbiological study. Minerva stomatologica 61, 381-398.
152. Pawar, R., Alqaied, A., Safavi, K., Boyko, J., and Kaufman, B. (2012). Influence of an apical negative
pressure irrigation system on bacterial elimination during endodontic therapy: a prospective
randomized clinical study. Journal of endodontics 38, 1177-1181.
153. Pelaez, J., Cogolludo, P.G., Serrano, B., Lozano, J.F., and Suarez, M.J. (2012). A prospective
evaluation of zirconia posterior fixed dental prostheses: three-year clinical results. The Journal of
prosthetic dentistry 107, 373-379.
154. Pera, C., Ueda, P., Casarin, R.C., Ribeiro, F.V., Pimentel, S.P., Casati, M.Z., and Cirano, F.R. (2012).
Double-masked randomized clinical trial evaluating the effect of a triclosan/copolymer dentifrice
on periodontal healing after one-stage full-mouth debridement. Journal of periodontology 83,
909-916.
155. Peres, M.F., Ribeiro, F.V., Ruiz, K.G., Nociti-Jr, F.H., Sallum, E.A., and Casati, M.Z. (2012). Steroidal and
non-steroidal cyclooxygenase-2 inhibitor anti-inflammatory drugs as pre-emptive medication in
patients undergoing periodontal surgery. Brazilian dental journal 23, 621-628.
156. Pesevska, S., Nakova, M., Gjorgoski, I., Angelov, N., Ivanovski, K., Nares, S., and Andreana, S. (2012).
Effect of laser on TNF-alpha expression in inflamed human gingival tissue. Lasers in medical science
27, 377-381.
157. Pietruska, M., Pietruski, J., Nagy, K., Brecx, M., Arweiler, N.B., and Sculean, A. (2012). Four-year results
following treatment of intrabony periodontal defects with an enamel matrix derivative alone or
combined with a biphasic calcium phosphate. Clinical oral investigations 16, 1191-1197.
158. Pradeep, A.R., Agarwal, E., and Naik, S.B. (2012). Clinical and microbiologic effects of commercially
available dentifrice containing aloe vera: a randomized controlled clinical trial. Journal of
periodontology 83, 797-804.
159. Pradeep, A.R., Kalra, N., Priyanka, N., Khaneja, E., Naik, S.B., and Singh, S.P. (2012). Systemic
ornidazole as an adjunct to non-surgical periodontal therapy in the treatment of chronic
periodontitis: a randomized, double-masked, placebo-controlled clinical trial. Journal of
periodontology 83, 1149-1154.
160. Pradeep, A.R., Kalra, N., Priyanka, N., and Naik, S.B. (2012). Microbiological outcomes of systemic
ornidazole use in chronic periodontitis. Part II. Journal of the International Academy of
Periodontology 14, 50-54.
161. Pradeep, A.R., Kumari, M., Priyanka, N., and Naik, S.B. (2012). Efficacy of chlorhexidine,
metronidazole and combination gel in the treatment of gingivitis--a randomized clinical trial. Journal
of the International Academy of Periodontology 14, 91-96.
162. Pradeep, A.R., Priyanka, N., Kalra, N., Naik, S.B., Singh, S.P., and Martande, S. (2012). Clinical efficacy
of subgingivally delivered 1.2-mg simvastatin in the treatment of individuals with Class II furcation
defects: a randomized controlled clinical trial. Journal of periodontology 83, 1472-1479.
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Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
163. Pradeep, A.R., Rao, N.S., Agarwal, E., Bajaj, P., Kumari, M., and Naik, S.B. (2012). Comparative
evaluation of autologous platelet-rich fibrin and platelet-rich plasma in the treatment of 3-wall
intrabony defects in chronic periodontitis: a randomized controlled clinical trial. Journal of
periodontology 83, 1499-1507.
164. Pradeep, A.R., Sharma, A., Rao, N.S., Bajaj, P., Naik, S.B., and Kumari, M. (2012). Local drug delivery
of alendronate gel for the treatment of patients with chronic periodontitis with diabetes mellitus: a
double-masked controlled clinical trial. Journal of periodontology 83, 1322-1328.
165. Putt, M.S., and Proskin, H.M. (2012). Custom tray application of peroxide gel as an adjunct to scaling
and root planing in the treatment of periodontitis: a randomized, controlled three-month clinical
trial. The Journal of clinical dentistry 23, 48-56.
166. Quirynen, M., and Van Assche, N. (2012). RCT comparing minimally with moderately rough implants.
Part 2: microbial observations. Clinical oral implants research 23, 625-634.
167. Ramel, C.F., Wismeijer, D.A., Hammerle, C.H., and Jung, R.E. (2012). A randomized, controlled
clinical evaluation of a synthetic gel membrane for guided bone regeneration around dental
implants: clinical and radiologic 1- and 3-year results. The International journal of oral & maxillofacial
implants 27, 435-441.
168. Rao, S.K., Setty, S., Acharya, A.B., and Thakur, S.L. (2012). Efficacy of locally-delivered doxycycline
microspheres in chronic localized periodontitis and on Porphyromonas gingivalis. Journal of
investigative and clinical dentistry 3, 128-134.
169. Ratka-Kruger, P., Mahl, D., Deimling, D., Monting, J.S., Jachmann, I., Al-Machot, E., Sculean, A.,
Berakdar, M., Jervoe-Storm, P.M., and Braun, A. (2012). Er:YAG laser treatment in supportive
periodontal therapy. Journal of clinical periodontology 39, 483-489.
170. Rioboo, M., Garcia, V., Serrano, J., O'Connor, A., Herrera, D., and Sanz, M. (2012). Clinical and
microbiological efficacy of an antimicrobial mouth rinse containing 0.05% cetylpyridinium chloride
in patients with gingivitis. International journal of dental hygiene 10, 98-106.
171. Rollke, L., Schacher, B., Wohlfeil, M., Kim, T.S., Kaltschmitt, J., Krieger, J., Krigar, D.M., Reitmeir, P., and
Eickholz, P. (2012). Regenerative therapy of infrabony defects with or without systemic doxycycline.
A randomized placebo-controlled trial. Journal of clinical periodontology 39, 448-456.
172. Rosema, N.A., van Palenstein Helderman, W.H., and Van der Weijden, G.A. (2012). Gingivitis and
plaque scores of 8- to 11-year-old Burmese children following participation in a 2-year school-based
toothbrushing programme. International journal of dental hygiene 10, 163-168.
173. Rutsatz, C., Baumhardt, S.G., Feldens, C.A., Rosing, C.K., Grazziotin-Soares, R., and Barletta, F.B.
(2012). Response of pulp sensibility test is strongly influenced by periodontal attachment loss and
gingival recession. Journal of endodontics 38, 580-583.
174. Saini, H.R., Tewari, S., Sangwan, P., Duhan, J., and Gupta, A. (2012). Effect of different apical
preparation sizes on outcome of primary endodontic treatment: a randomized controlled trial.
Journal of endodontics 38, 1309-1315.
175. Samnieng, P., Ueno, M., Shinada, K., Zaitsu, T., and Kawaguchi, Y. (2012). Daily variation of oral
malodour and related factors in community-dwelling elderly Thai. Gerodontology 29, e964-971.
176. Samuels, N., Grbic, J.T., Saffer, A.J., Wexler, I.D., and Williams, R.C. (2012). Effect of an herbal mouth
rinse in preventing periodontal inflammation in an experimental gingivitis model: a pilot study.
Compendium of continuing education in dentistry 33, 204-206, 208-211.
177. Santos, V.R., Ribeiro, F.V., Lima, J.A., Miranda, T.S., Feres, M., Bastos, M.F., and Duarte, P.M. (2012).
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Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
Partial- and full-mouth scaling and root planing in type 2 diabetic subjects: a 12-mo follow-up of
clinical parameters and levels of cytokines and osteoclastogenesis-related factors. Journal of
periodontal research 47, 45-54.
178. Satyanarayana, K.V., Anuradha, B.R., Srikanth, G., Chandra, P.M., Anupama, T., and Durga, P.M.
(2012). Clinical evaluation of intrabony defects in localized aggressive periodontitis patients with
and without bioglass- an in-vivo study. Kathmandu University medical journal (KUMJ) 10, 11-15.
179. Schwarz, F., John, G., Mainusch, S., Sahm, N., and Becker, J. (2012). Combined surgical therapy of
peri-implantitis evaluating two methods of surface debridement and decontamination. A two-year
clinical follow up report. Journal of clinical periodontology 39, 789-797.
180. Schwarz, F., Sahm, N., and Becker, J. (2012). Impact of the outcome of guided bone regeneration in
dehiscence-type defects on the long-term stability of peri-implant health: clinical observations at 4
years. Clinical oral implants research 23, 191-196.
181. Sezer, U., Eltas, A., Ustun, K., Senyurt, S.Z., Erciyas, K., and Aras, M.H. (2012). Effects of low-level laser
therapy as an adjunct to standard therapy in acute pericoronitis, and its impact on oral
health-related quality of life. Photomedicine and laser surgery 30, 592-597.
182. Sharma, A., and Pradeep, A.R. (2012). Clinical efficacy of 1% alendronate gel as a local drug
delivery system in the treatment of chronic periodontitis: a randomized, controlled clinical trial.
Journal of periodontology 83, 11-18.
183. Sharma, A., and Pradeep, A.R. (2012). Clinical efficacy of 1% alendronate gel in adjunct to
mechanotherapy in the treatment of aggressive periodontitis: a randomized controlled clinical trial.
Journal of periodontology 83, 19-26.
184. Sharma, N.C., Klukowska, M., Mielczarek, A., Grender, J.M., and Qaqish, J. (2012). A 4-week clinical
comparison of a novel multi-directional power brush to a manual toothbrush in the reduction of
gingivitis and plaque. American journal of dentistry 25 Spec No A, 14A-20A.
185. Sharma, N.C., Lyle, D.M., Qaqish, J.G., and Schuller, R. (2012). Comparison of two power interdental
cleaning devices on the reduction of gingivitis. The Journal of clinical dentistry 23, 22-26.
186. Shibly, O., Kutkut, A., Patel, N., and Albandar, J.M. (2012). Immediate implants with immediate
loading vs. conventional loading: 1-year randomized clinical trial. Clinical implant dentistry and
related research 14, 663-671.
187. Shoreibah, E.A., Ibrahim, S.A., Attia, M.S., and Diab, M.M. (2012). Clinical and radiographic
evaluation of bone grafting in corticotomy-facilitated orthodontics in adults. Journal of the
International Academy of Periodontology 14, 105-113.
188. Siadat, H., Bassir, S.H., Alikhasi, M., Shayesteh, Y.S., Khojasteh, A., and Monzavi, A. (2012). Effect of
static magnetic fields on the osseointegration of immediately placed implants: a randomized
controlled clinical trial. Implant dentistry 21, 491-495.
189. Siadat, H., Panjnoosh, M., Alikhasi, M., Alihoseini, M., Bassir, S.H., and Rokn, A.R. (2012). Does implant
staging choice affect crestal bone loss? Journal of oral and maxillofacial surgery : official journal of
the American Association of Oral and Maxillofacial Surgeons 70, 307-313.
190. Silva, J.A., Lopes Ferrucci, D., Peroni, L.A., de Paula Ishi, E., Rossa-Junior, C., Carvalho, H.F., and
Stach-Machado, D.R. (2012). Periodontal disease-associated compensatory expression of
osteoprotegerin is lost in type 1 diabetes mellitus and correlates with alveolar bone destruction by
regulating osteoclastogenesis. Cells, tissues, organs 196, 137-150.
191. Simsek Kaya, G., Yapici Yavuz, G., Sumbullu, M.A., and Dayi, E. (2012). A comparison of diode laser
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Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
and Er:YAG lasers in the treatment of gingival melanin pigmentation. Oral surgery, oral medicine,
oral pathology and oral radiology 113, 293-299.
192. Singh, M., Stark, P.C., Damoulis, P.D., Levi, P., and Griffin, T.J. (2012). Trap door: an alternative
procedure to the triangular distal wedge for the elimination of distal periodontal pockets adjacent
to edentulous areas. Compendium of continuing education in dentistry 33, e38-44.
193. Sisti, A., Canullo, L., Mottola, M.P., Covani, U., Barone, A., and Botticelli, D. (2012). Clinical evaluation
of a ridge augmentation procedure for the severely resorbed alveolar socket: multicenter
randomized controlled trial, preliminary results. Clinical oral implants research 23, 526-535.
194. Slot, D.E., Timmerman, M.F., Versteeg, P.A., van der Velden, U., and van der Weijden, F.A. (2012).
Adjunctive clinical effect of a water-cooled Nd:YAG laser in a periodontal maintenance care
programme: a randomized controlled trial. Journal of clinical periodontology 39, 1159-1165.
195. Slotte, C., Asklow, B., Sultan, J., and Norderyd, O. (2012). A randomized study of open-flap surgery of
32 intrabony defects with and without adjunct bovine bone mineral treatment. Journal of
periodontology 83, 999-1007.
196. Slotte, C., Lenneras, M., Gothberg, C., Suska, F., Zoric, N., Thomsen, P., and Nannmark, U. (2012).
Gene expression of inflammation and bone healing in peri-implant crevicular fluid after placement
and loading of dental implants. A kinetic clinical pilot study using quantitative real-time PCR. Clinical
implant dentistry and related research 14, 723-736.
197. Sobottka, I., Wegscheider, K., Balzer, L., Boger, R.H., Hallier, O., Giersdorf, I., Streichert, T., Haddad, M.,
Platzer, U., and Cachovan, G. (2012). Microbiological analysis of a prospective, randomized,
double-blind trial comparing moxifloxacin and clindamycin in the treatment of odontogenic
infiltrates and abscesses. Antimicrobial agents and chemotherapy 56, 2565-2569.
198. Soo, L., Leichter, J.W., Windle, J., Monteith, B., Williams, S.M., Seymour, G.J., and Cullinan, M.P. (2012).
A comparison of Er:YAG laser and mechanical debridement for the non-surgical treatment of
chronic periodontitis: a randomized, prospective clinical study. Journal of clinical periodontology
39, 537-545.
199. Spinato, S., Agnini, A., Chiesi, M., Agnini, A.M., and Wang, H.L. (2012). Comparison between graft
and no-graft in an immediate placed and immediate nonfunctional loaded implant. Implant
dentistry 21, 97-103.
200. Stenman, J., Lundgren, J., Wennstrom, J.L., Ericsson, J.S., and Abrahamsson, K.H. (2012). A single
session of motivational interviewing as an additive means to improve adherence in periodontal
infection control: a randomized controlled trial. Journal of clinical periodontology 39, 947-954.
201. Stoker, G., van Waas, R., and Wismeijer, D. (2012). Long-term outcomes of three types of
implant-supported mandibular overdentures in smokers. Clinical oral implants research 23, 925-929.
202. Suzuki, N., Tanabe, K., Takeshita, T., Yoneda, M., Iwamoto, T., Oshiro, S., Yamashita, Y., and Hirofuji, T.
(2012). Effects of oil drops containing Lactobacillus salivarius WB21 on periodontal health and oral
microbiota producing volatile sulfur compounds. Journal of breath research 6, 017106.
203. Tangade, P.S., Mathur, A., Tirth, A., and Kabasi, S. (2012). Anti-gingivitis effects of Acacia
arabica-containing toothpaste. The Chinese journal of dental research : the official journal of the
Scientific Section of the Chinese Stomatological Association (CSA) 15, 49-53.
204. Telleman, G., Raghoebar, G.M., Vissink, A., and Meijer, H.J. (2012). Impact of platform switching on
inter-proximal bone levels around short implants in the posterior region; 1-year results from a
randomized clinical trial. Journal of clinical periodontology 39, 688-697.
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205. Thakare, K., and Deo, V. (2012). Randomized controlled clinical study of rhPDGF-BB + beta-TCP
versus HA + beta-TCP for the treatment of infrabony periodontal defects: clinical and radiographic
results. The International journal of periodontics & restorative dentistry 32, 689-696.
206. Theodoro, L.H., Silva, S.P., Pires, J.R., Soares, G.H., Pontes, A.E., Zuza, E.P., Spolidorio, D.M., de Toledo,
B.E., and Garcia, V.G. (2012). Clinical and microbiological effects of photodynamic therapy
associated with nonsurgical periodontal treatment. A 6-month follow-up. Lasers in medical science
27, 687-693.
207. Tonetti, M.S., Lang, N.P., Cortellini, P., Suvan, J.E., Eickholz, P., Fourmousis, I., Topoll, H., Vangsted, T.,
and Wallkamm, B. (2012). Effects of a single topical doxycycline administration adjunctive to
mechanical debridement in patients with persistent/recurrent periodontitis but acceptable oral
hygiene during supportive periodontal therapy. Journal of clinical periodontology 39, 475-482.
208. Trombelli, L., Simonelli, A., Schincaglia, G.P., Cucchi, A., and Farina, R. (2012). Single-flap approach
for surgical debridement of deep intraosseous defects: a randomized controlled trial. Journal of
periodontology 83, 27-35.
209. Turkyilmaz, I., Tozum, T.F., Fuhrmann, D.M., and Tumer, C. (2012). Seven-year follow-up results of
TiUnite implants supporting mandibular overdentures: early versus delayed loading. Clinical implant
dentistry and related research 14 Suppl 1, e83-90.
210. Tuzuner, T., Alacam, A., Altunbas, D.A., Gokdogan, F.G., and Gundogdu, E. (2012). Clinical and
radiographic outcomes of direct pulp capping therapy in primary molar teeth following
haemostasis with various antiseptics: a randomised controlled trial. European journal of paediatric
dentistry : official journal of European Academy of Paediatric Dentistry 13, 289-292.
211. Urban, T., Kostopoulos, L., and Wenzel, A. (2012). Immediate implant placement in molar regions: a
12-month prospective, randomized follow-up study. Clinical oral implants research 23, 1389-1397.
212. Urban, T., Kostopoulos, L., and Wenzel, A. (2012). Immediate implant placement in molar regions: risk
factors for early failure. Clinical oral implants research 23, 220-227.
213. Van Assche, N., Coucke, W., Teughels, W., Naert, I., Cardoso, M.V., and Quirynen, M. (2012). RCT
comparing minimally with moderately rough implants. Part 1: clinical observations. Clinical oral
implants research 23, 617-624.
214. Vandeweghe, S., and De Bruyn, H. (2012). A within-implant comparison to evaluate the concept of
platform switching: a randomised controlled trial. European journal of oral implantology 5, 253-262.
215. Vera, J., Siqueira, J.F., Jr., Ricucci, D., Loghin, S., Fernandez, N., Flores, B., and Cruz, A.G. (2012). One-
versus two-visit endodontic treatment of teeth with apical periodontitis: a histobacteriologic study.
Journal of endodontics 38, 1040-1052.
216. Vigolo, P., Mutinelli, S., Givani, A., and Stellini, E. (2012). Cemented versus screw-retained
implant-supported single-tooth crowns: a 10-year randomised controlled trial. European journal of
oral implantology 5, 355-364.
217. Wang, H.L., Okayasu, K., Fu, J.H., Hamerink, H.A., Layher, M.G., and Rudek, I.E. (2012). The success
rate of narrow body implants used for supporting immediate provisional restorations: a pilot
feasibility study. Implant dentistry 21, 467-473.
218. Windisch, P., Stavropoulos, A., Molnar, B., Szendroi-Kiss, D., Szilagyi, E., Rosta, P., Horvath, A., Capsius,
B., Wikesjo, U.M., and Sculean, A. (2012). A phase IIa randomized controlled pilot study evaluating
the safety and clinical outcomes following the use of rhGDF-5/beta-TCP in regenerative periodontal
therapy. Clinical oral investigations 16, 1181-1189.
84

Appendix E – Randomized Controlled Trials Abstracts Included for Eligibility Analysis
219. Winning, L., Polyzois, I., Nylund, K., Kelly, A., and Claffey, N. (2012). A placebo-controlled trial to
evaluate an anesthetic gel when probing in patients with advanced periodontitis. Journal of
periodontology 83, 1492-1498.
220. Wohlfahrt, J.C., Lyngstadaas, S.P., Ronold, H.J., Saxegaard, E., Ellingsen, J.E., Karlsson, S., and Aass,
A.M. (2012). Porous titanium granules in the surgical treatment of peri-implant osseous defects: a
randomized clinical trial. The International journal of oral & maxillofacial implants 27, 401-410.
221. Wolfart, S., Marre, B., Wostmann, B., Kern, M., Mundt, T., Luthardt, R.G., Huppertz, J., Hannak, W.,
Reiber, T., Passia, N., et al. (2012). The randomized shortened dental arch study: 5-year
maintenance. Journal of dental research 91, 65S-71S.
222. Yaman, E., Gorken, F., Pinar Erdem, A., Sepet, E., and Aytepe, Z. (2012). Effects of folk medicinal
plant extract Ankaferd Blood Stopper((R)) in vital primary molar pulpotomy. European archives of
paediatric dentistry : official journal of the European Academy of Paediatric Dentistry 13, 197-202.
223. Yilmaz, H.G., and Bayindir, H. (2012). Clinical evaluation of chlorhexidine and essential oils for
adjunctive effects in ultrasonic instrumentation of furcation involvements: a randomized controlled
clinical trial. International journal of dental hygiene 10, 113-117.
224. Yilmaz, S., Kut, B., Gursoy, H., Eren-Kuru, B., Noyan, U., and Kadir, T. (2012). Er:YAG laser versus
systemic metronidazole as an adjunct to nonsurgical periodontal therapy: a clinical and
microbiological study. Photomedicine and laser surgery 30, 325-330.
225. Zingale, J., Harpenau, L., Bruce, G., Chambers, D., and Lundergan, W. (2012). The effectiveness of
scaling and root planing with adjunctive time-release minocycline using an open and closed
approach for the treatment of periodontitis. General dentistry 60, 300-305.
226. Zingale, J., Harpenau, L., Chambers, D., and Lundergan, W. (2012). Effectiveness of root planing with
diode laser curettage for the treatment of periodontitis. Journal of the California Dental Association
40, 786-793.
227. Zucchelli, G., Marzadori, M., Mele, M., Stefanini, M., and Montebugnoli, L. (2012). Root coverage in
molar teeth: a comparative controlled randomized clinical trial. Journal of clinical periodontology
39, 1082-1088.
85

Appendix F - Abstracts excluded by screening the initial 227 abstracts
Abstracts excluded by screening the initial 227 abstracts
Abstract # Reason for exclusion
7 RCT- Endodontics
16 RCT- Third molar surgery, no periodontal outcomes mentioned
21 RCT- Endodontics
49 RCT- Endodontics
70 RCT- Third molar surgery, no periodontal outcomes mentioned
71 RCT- Endodontics
84 Observational study
94 RCT- Endodontics
97 RCT- Endodontics
99 Cost effectiveness study based on RCT
104 RCT- Radicular cyst enucleation study
109 Primarily an in vitro study
147 RCT- Endodontics
149 RCT- Endodontics
152 RCT- Endodontics
173 Observational study
174 RCT- Endodontics
175 Observational study
190 Animal study
199 Observational study
210 RCT- Endodontics
215 RCT- Endodontics
222 RCT- Endodontics
Total excluded abstracts = 23

86

Appendix G - Abstracts for which full text articles were obtained to confirm eligibility for analyses with the
CONSORT RCT Abstract Checklist*
Abstracts for which full text articles were obtained to confirm eligibility for analyses with the CONSORT RCT
Abstract Checklist*
Included Excluded Reason for exclusion
Abstract # Abstract #
1 20 In vitro study
15 85 Observational study
34 93 Observational study
35 98 Observational study
40 120 RCT- Prosthodontics, no primary periodontal outcomes mentioned
51 153 RCT- Prosthodontics, no primary periodontal outcomes mentioned
59 Total excluded abstracts: 6

65
77
86
91
95
100
101
117
153
164
168
177
179
187
196
209

* Only the Objective and/or Material & Methods section was scanned to confirm if the study was a
randomized controlled trial or not and the entire article was not read to prevent bias during abstract
evaluation.
87

Appendix H - Abstracts and checklist questions discussed with a second reviewer
Abstract # Item/question #
15 Confirm eligibility for inclusion
18 16
22 8
23 18
24 16
26 16, 17
27 19
30 14
31 20
32 16
36 20
37 16
40 14
48 16
51 14
53 16
55 20
56 14, 15
59 Confirm eligibility for inclusion
87 20
134 16, 20
160 16
225 20

88

Abstract (if available)

Abstract INTRODUCTION: Randomized controlled trials (RCT) by proper design, conduct, analysis and reporting, provide reliable information in clinical care. Reporting of RCT abstracts is of equal importance as there is evidence that many clinicians will change their clinical decisions based on RCT abstracts. The reporting quality of RCT abstracts has been suboptimal. It is not clear whether the reporting quality is related to the journal metrics. The main objective of this study is to conduct a cross-sectional survey to evaluate the reporting quality of randomized controlled trials of periodontal diseases in journal abstracts and to perform a bibliometric analysis. The null hypothesis was there is no association between the journal metrics (5-Year Impact Factor, Eigenfactor® Score and Article Influence® Score), abstract metrics (Word Count, Number of authors), journal endorsement of Consolidated Standards of Reporting Trials (CONSORT) and the overall quality of reporting of CONSORT RCT modified checklist questions. ❧ MATERIALS AND METHODS: CONSORT RCT Abstract Extension checklist with explanation and elaboration was utilized and modified to assess the quality of reporting of RCT abstracts of periodontal diseases in the journal abstracts in the year 2012. Bibliometric analysis of journal metrics (5-year impact factor, Eigenfactor® Score and Article Influence® Score) and abstract metrics (number of authors, abstract word count), the geographic distribution and the CONSORT endorsing journal abstracts was compared to the reporting quality of RCT abstracts in periodontal diseases. Calibration and intra-rater agreement was done prior to the data collection and analysis. A second reviewer was consulted for independent evaluation and clarification as needed. For descriptive analysis, the values of continuous variables were expressed as median and interquartile ranges and as proportion percent for binary categorical variables. For association analysis between binary (yes/no) response variable and the continuous variable, Mann-Whitney test (for independent samples) was used. For examining the association between 2 categorical variables, Fishers exact test was used. Chi-square test was performed to examine the association between two sets of binary response variables (yes/no). A p-value of <0.05 was considered statistically significant. All analyses were conducted using SAS v9.4. ❧ RESULTS: A total of 198 RCT abstracts of periodontal diseases in the year 2012 from 57 journals were included in the study. Fifteen journals, listed as endorsers of CONSORT, contributed 108 RCT. Four journals (Journal of periodontology, Journal of clinical periodontology, Clinical oral implants research, and European journal of oral implantology) contributed 84/198 RCT in 2012. European countries contributed the majority (n=81, 40.91%) of RCT abstracts followed by Asia (51, 25.76%), North America (33, 16.67%), South America (23, 11.62%), Africa (7, 3.54%), and Oceania (1, 0.51%). All 7 RCT from Africa, a continent with 54 countries, originated from one country, Egypt. Among 31 countries in this study, United States contributed the most RCT (n=28, 14.14%) followed by India (24, 12.12%), Italy (n=22, 11.11%) and Brazil (n=20, 10.1%). The frequency of journal metrics were 5-Year Impact Factor (Median 2.316

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Creator Kumar, Satish S. (author)

Core Title Reporting quality of randomized controlled trials of periodontal diseases in journal abstracts: a cross-sectional survey and bibliometric analysis

School School of Dentistry

Degree Master of Science

Degree Program Craniofacial Biology

Publication Date 07/06/2015

Defense Date 05/14/2015

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag bibliometric analysis,cross-sectional survey,journal abstracts,OAI-PMH Harvest,periodontal diseases,reporting quality

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Advisor Kar, Kian (committee chair), Paine, Michael L. (committee member), Sameshima, Glenn T. (committee member)

Creator Email satish.kumar@usc.edu,satish.shyamkumar@gmail.com

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