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3D volumetric changes of tissue contour after immediate implant placement with and without xenograft in the horizontal gap: a randomized controlled clinical trial
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3D volumetric changes of tissue contour after immediate implant placement with and without xenograft in the horizontal gap: a randomized controlled clinical trial
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1
3D Volumetric changes of Tissue Contour after
immediate Implant Placement with and without
Xenograft in the Horizontal Gap: A Randomized
Controlled Clinical Trial
Author:
Ramón Ceballos Gavilán
Division of Periodontology, Diagnostic Sciences & Dental Hygiene
University of Southern California
Ostrow School of Dentistry
925 34th Street Room 4278
Los Angeles, CA 90089-0641
A Thesis to be presented to the
FACULTY OF THE OSTROW SCHOOL OF DENTISTRY OF UNIVERSITY OF
SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
MASTER OF SCIENCE
(CRANIOFACIAL BIOLOGY)
August 2017
2
Table of Contents:
1. Title……………………………………..3
2. Abstract…………………………...…….4
3. Introduction……………………………..5
4. Materials and Methods………………….7
5. Results…………………………………12
6. Discussion……………………………...15
7. References……………………………..19
3
4
1. Title:
3D Volumetric changes of Tissue Contour after immediate Implant Placement
with and without Xenograft in the Horizontal Gap: A Randomized Controlled
Clinical Trial
5
2. Abstract:
Introduction: Following extraction of an anterior maxillary tooth and immediate implant placement,
complications can arise due to the changes that occur in the periodontal tissues. The aim of this randomized
controlled clinical trial was to evaluate whether placement of bone graft in the facial gap at immediately
placed implants in the anterior maxilla influences the position of the mid-facial mucosal zenith.
Methods: Patients with a need for a single-tooth replacement in the anterior maxilla, were enrolled in this
study. Following tooth extraction, implants with sloped platform (Astra Tech Osseospeed Tx Profile) were
placed into the extraction sockets without flap elevation. Randomly assigned experimental sites received
anorganic bovine bone mineral (ABBM) in the facial gap, while the gap in control sites were left unfilled.
Impressions were obtained at baseline and one year after the date of implantation. Dental stone casts were
optically scanned and STL files were imported into reverse engineering software (Geomagic Control) for 3D
quantitative analysis. Linear and volumetric measurements were performed to evaluate the dimensional
alterations, including positional changes of the mid-facial mucosal zenith, the mesial and distal papilla height
position change, 3D volumetric changes on the tissues apical to the mucosal zenith as well as horizontal
contour changes at 1, 2, 3, 4, 5 mm from the position of the pre-operative gingival margin.
Results: Patients in both test and control group healed uneventfully after implant placement. The mean
mucosal zenith change in the grafted and non-grafted groups were 0.82 ± 0.53 mm and -1.1 ± 0.64 mm,
respectively. There were no statistically differences between two groups. The mean mesial papilla loss loss
were 0.89 ± 0.41 mm and 0.95 ± 0.62 mm for the control and test groups, respectively. The mean distal
papilla loss were 0.84 ± 0.5 mm and 0.84 ± 0.46 mm for the control and test groups, respectively. These
results were not statistically significant different. In the control group, the mean horizontal dimensional
changes at 1, 2, 3, 4, 5 mm relative to the pre-operative midfacial gingival zenith were -0.62 ± 0.41 mm, -0.74
± 0.42 mm, -0.71 ± 0.32 mm, -0.71 ± 0.33 mm, -0.76 ± 0.36 mm, respectively. In the test group, the mean
horizontal dimensional changes in the same positions were -0,94 ± 0.48 mm, -0.82 ± 0.63 mm, -0.77 ± 0.61
mm, -0.74 ± 0.53 mm, -0.67 ± 0.51 mm, respectively. There was no statistically difference between two
groups. The mean volume loss was 3222 ± 7360 mm3 and 1313 ± 2563 mm3 for the control and test group
respectively, this difference was not statistically significant different.
Conclusions: The results of this study demonstrated that, when utilizing the particular protocol of this study
with careful flapless tooth extraction, implant placement with at least 2mm horizontal gap to the facial
alveolar bone, implant with sloped platform, only minor mucosal dimensional changes in soft tissue surface
mucosa were observed. The addition of ABBM in the horizontal gap of the socket failed to show the positive
influence in the outcome of the facial peri-implant surface mucosa.
6
3. Introduction:
Due to post-extraction bone resorption, peri-implant mucosa defect, mal-implant position, one of the major
challenges in implant dentistry when replacing an anterior maxillary tooth is to achieve a satisfactory esthetic
outcome. The key to facilitate successful treatment outcome in implant dentistry is to understand the
biological response of alveolar alteration including hard and soft tissue change followed by tooth extraction.
One of detrimental factors leading to the esthetic complication of implant dental treatment is the malposition
of implant placement (Schneider et al. 1999). This may be attributed to insufficient horizontal bone width
when placing implants due to significant amount of alveolar ridge dimensional loss after tooth extraction
(Araujo et al. 2005). Several animal and clinical studies have demonstrated that bone resorption occurred
followed by tooth extraction without any interventional therapy (Araujo et al. 2005, Schropp et al. 2003, Min
et al. 2016, Omran et al. 2016, Ryu et al. 2016, Abdelhamid et al. 2016). Experimental studies (Araujo et al.
2005, Schropp et al. 2003, Cardaropoli et al. 2003) explained the basic biology events of wound healing of
extraction socket. This healing dynamics were described as following healing stages: (i) at day 3, blood clot
was present in the socket, (ii) at day 7, a provisional matrix started replacing the clot, (iii) at day 14, woven
bone is formed in the extraction socket, (iv) at day 30, mineralized bone is found that (v) bone marrow is
organized at day 60, and (vi) increases it’s presence by day 180. At the same time as this healing process
takes place, the alveolar processes undergo remodeling (Cardaropoli et al. in 2003). As a consequence of this
remodeling, there is a loss of the buccolingual and apicocoronal dimensions of the alveolar ridge (Atwood et
al. 1963, Wilderman et al. 1963, Araujo et al. 2005, Van der Weijden et al. 2009). This volume loss can be
attributed to the resorption of bundle bone due to periodontal ligament dissection when removing tooth
(Araujo et al. 2005). Furthermore, deficiency of blood circulation within the buccal bone after tooth removal
drives to prominent destruction of facial bone (Cutright et al. 1969).
A recent systematic review (Hammerle et al. 2012) concluded that alveolar ridge undergoes both horizontal
and vertical dimensional loss up to 3.8 mm and 1.24 mm, respectively. Moreover, recent canine study (Ryu et
al. 2017) demonstrated the mean alveolar horizontal bone loss in unassisted healing group takes place 0.25
mm per week for the first three month. A clinical study (Zadeh et al. 2016) revealed that soft tissue collapse
followed by tooth extraction was prominent especially most coronal 3 mm crest zone, although this collapse
was observed up to 6 mm apical to crest. The horizontal loss of volume of the ridge after 1 year may
correspond to 50% of the total width of the ridge (Schropp et al. 2003).
Although the resorption of buccal bone wall is not fully understood, the reason why the buccal plate tends to
resorb more than the lingual plate, is because in its most coronal part, which is the thinnest, it´s composed
exclusively by bundle bone. After tooth extraction, the bundle bone loses its function, and resorbs
(Cardaropoli et al. 2003). These findings are in agreement with the results obtained by other studies
(Pietrokovski et al. 1967, Schropp et al. 2003, Barone et al. 2008).
A human study reported that the thickness of buccal bone wall should be considered as a prognostic factor
influencing the degree of post-tooth extraction bone resorption. In addition to alveolar bone change, soft
tissue dimensional alteration has been evaluated by Chappuis et al. (2013) and revealed that a thin buccal
bone wall (< 1.0 mm) exhibited vertical dimensional loss of 7.5 mm, while dimensional loss in thick buccal
bone wall (>1.0mm) is 1.1 mm when maxillary anterior tooth was removed.
Although there is neither available surgical approach nor biomaterials to reverse such inevitable biological
response of wound healing of extraction tooth socket, several preclinical and clinical studies demonstrated the
benefit of interventional therapies to minimize the post-extraction alveolar dimensional alteration. Ridge
preservation utilizing various biomaterials (Chappius et al. 2017) and/or barrier membrane (Meltzer et al.
1995), extraction socket devices (Zadeh et al. 2015), punch free gingival graft (Jung et al. 2004) has been
recommended to minimize the degree of post-op alveolar dimensional change. A systematic review (Vigoletti
et al. 2013) concluded that ridge preservation exhibited greater reduction in bone height loss and width loss
(1.47 mm, 1.83 mm, respectively).
7
Boticelli et al. in 2004 investigated the dimensional alterations of hard tissues that occur following tooth
extraction and immediate placement of implants. They measured the changes that occurred on the ridge and
observed that the horizontal resorption of the buccal bone dimension amounted to about 56% and the
corresponding resorption of the lingual/ palatal bone was 30%. The results of this study conclude that
immediate implants do not minimize the amount of resorption post-extraction. Several studies (Covani et a
2004, Ferrus et al 2009, Sanz 2009, Clementini et al. 2015) have also demonstrated that immediate implants
do not preserve the ridge volume after a tooth extraction, contradicting previous studies that had hypothesized
that it would (Shanaman et al 1992, Denissen et al. 1993, Watzek et al. 1995, Sclar et al. 1999, Paulantonio et
al 2001).
Moreover, recent randomized clinical trial (Sanz et al. 2016) evaluated the added value of graft placement in
gap between implant and facial bone when performing immediate implant placement. The result of this study
revealed that only sites with a thin (<1mm) buccal plate benefited from the use of a bone graft in the facial
gap. These conclusions are in agreement with the meta-analysis published in 2015 by Clementini et al.
Therefore, as immediate implants won´t avoid the amount of resorption that happens, it has proposed in a
recent study (Chappius 2017) that immediate implants are indicated in cases that have a thick buccal bone
plate and a thick biotype. At the same time, other studies have described the buccal soft tissue around anterior
maxillary teeth to be in most of the cases 0.5-1mm in thickness (Muler et al 2000, Sharma et al 2014), so this
protocol should be used in specific cases.
Knowing this body of literature, a protocol minimizing the aesthetic complications following immediate
implant placement was assessed by using a sloped platform implant. The difference in the height of implant
shoulder at buccal and palatal aspect is 1.5 mm. As shown by Araujo in 2005, the buccal plate resorbs
vertically 1.9 mm more than the palatal plate, therefore we hypothesized that if we used a sloped implant, the
addition of a xenograft in the facial gap, could influence the soft tissue contours. In a prospective randomized
controlled clinical trial, (Sanz et al. 2010) the bone resorption that happened after immediate implants
placement was studied, and an uneven resorption amount was seen between the buccal and the palatal aspects
of the ridge. The buccal plate suffered a vertical reduction that was twice the amount of the palatal plate.
These results are in contrast with animal (Araujo et al. 2005) and human studies (Boticceli et al. 2004). This
uneven resorption means that when placing an immediate implant, for it to be at the level of the bone crest
after complete healing, either some ostectomy at the palatal aspect, some threads exposure with it´s
consequent esthetic complication or the need of bone augmentation procedure. Another alternative to this
issue, is the placement of a sloped platform implant, being it´s buccal aspect shorter than the palatal, to
counteract the increased resorption that occurs on the buccal plate. Noelken et al. in 2014 conducted a
multicenter prospective study, where they placed 65 sloped configuration implant in healed sloped ridges.
They reported that after 1 year from implant placement, the mean bone level change was 0.54mm, being able
to keep the sloped configuration of the ridge, with a minimal remodeling.
Since the lack of evidence on the need of grafting in the gap after sloped platform immediate implant
placement for alveolar dimensional alteration, the present study sought to evaluate the benefit of sloped
platform immediate implant placement with graft in the gap for peri-implant mucosa stability by three-
dimensional reverse engineering software.
Therefore, the purpose of this study was to evaluate whether placement of bone graft in the facial gap at
immediately placed implants in the anterior maxilla influences the position of the mid-facial mucosal zenith
one year post-implant placement. Furthermore, the dimensional changes at the mesial and distal papillae, the
changes in soft tissue volume as well as horizontal contour changes at 1, 2, 3, 4, and 5 mm below the position
of the initial midfacial gingival margin at midfacial were evaluated.
8
4. Material and Methods:
Study Protocol:
The protocol of this study was approved by the Institutional Review Board of the University of North
Carolina, as well as the Western IRB. All patients gave their consent before the start of the procedures. This
study report has followed the CONSORT reporting guidelines (supplemental Table 1) for randomized
controlled trials (Moher et al 2010).
The present study was designed as a prospective randomized controlled parallel-arm multicenter clinical trial.
The primary outcome was to assess the vertical mucosal mid-zenith position change from baseline to 1 year
post implant placement. Two intervention groups compared management of the horizontal gap between the
implant and the alveolar facial plate, where in the test group the gap was filled with anorganic bovine bone
mineral (ABBM) and in the control group the gap was left unfilled.
Two centers participated in this study, a private periodontal practice in Southern California and the
department of Prosthodontics of the University of North Carolina at Chapel Hill.
Study Population:
The patients were enrolled between October 1
st
, 2011 and March 2013.
Patients with a need for a single-tooth replacement in the anterior maxilla, were enrolled in this study if they
fulfilled the following inclusion criteria:
• Have one of tooth in the maxillary right first premolar to left first premolar location requiring
extraction and implant placement
• Have natural teeth adjacent to proposed site
• Age 18-75
• Available for one year follow-up
• Consent to trial
The exclusion criteria were as follows:
• Untreated caries or periodontal disease
• Smoker within past six months
• ASA Class 3+, immunocompromised patients
• Pregnant or plan to be within six months
• Severe bruxism
• History of bisphosphonate use
Study outcome measures:
The primary outcome examined in this study was measurement of vertical change of mucosal zenith. The
secondary outcome measure was quantitation of changes in horizontal width of the alveolar bone at the zenith
of the gingival margin of the pre-operative STL file, at 1 mm, 2 mm, 3 mm, 4 mm and 5 mm apical to the
mucosal margin. The tertiary outcome measure was the volume change in the facial mucosal tissue. The
quaternary outcome measure was the vertical change of the mesial and distal papillae.
Intervention and follow-up:
9
Anterior maxillary teeth that were treatment planned for extraction, were selected for this study. Extraction
were performed as atraumatically as possible, using either the Easy X-TRAC System (A. Titan, Orchard Park,
NY) or the PIEZOSURGERY® (Piezosurgery, Columbus, Ohio) with the Extraction Kit inserts. Sockets
were debrided thoroughly to remove any soft tissue remnants that could interfere with healing. If a dehiscence
was seen in the facial plate, patient was excluded.
Osteotomy for implant placement was performed per the manufacturers recommendation for Astra Tech
Osseospeed Profile Tx (Astra Tech AB). Randomly assigned experimental sites received ABBM in the facial
gap (Fig. 2), while the gap in control sites were left unfilled (Fig.1). Randomization was performed using
“Random allocation software” (http://mahmoodsaghaei.tripod.com/Softwares/randalloc.html, Iran). The
ABBM was hydrated in sterile saline solution and inserted into the socket before implant placement, while the
final drill remained in place in the socket, to assure the material reaching the most apical portion of the
alveolar socket. Implants with sloped platform (Astra Tech Osseospeed Tx Profile) were placed into the
extraction sockets without flap elevation. The implants were palatally positioned and a minimum of 2 mm gap
was present between the implant and the facial plate in all cases. No suturing was used in any of the cases.
Fig. 1. Clinical case from the control group. (A)Tooth extraction performed. (B) Sloped platform implant
inserted into the socket. (C) Final position of the implant.
Fig. 2. Clinical case from the test group. (D) Extraction was performed and bone graft placed in the buccal
gap. (E) Sloped platform implant beinf inserted into the scket. (F) Final position of the implant with the facial
gap filled with bone graft.
Healing abutments were placed on the implants. Patients were provisionalized with a removable appliance or
bonded bridge without compression on the tissues during the healing period. Post-surgical instructions were
given to the participants, and medications prescribed included, chlorhexidine gluconate 0.12% oral rinse used
twice a day for 2 weeks, antibiotics started 1 hour pre-operatively and continued for one week, as well as
analgesic.
Four months healing period was allowed before the implant was restored. Implant supported provisional
restorations were made until the definitive restoration was finally delivered.
Impressions were obtained at baseline and one year after the date of implantation. All casts were scanned
using an extraoral scanner (D250; 3Shape, Copenhagen, Denmark). The scanned images were exported in a
Standard Tesselation Language (STL; 3D Systems, Rock Hill, SC) format. The baseline and 1 year post op
STL files were then imported to the Geomagic® Control X™ software (3D Systems, Rock Hill, SC) and were
superimposed.
The analysis was performed blindly by one examiner (RCG), who was not aware of the group allocation until
the analyses were completed. The superimposition of the models was performed using the adjacent teeth, and
10
a maximum deviation of ±0.16mm was allowed, if the deviation was greater, the models were superimposed
again. (Fig. 3)
Fig. 3. Superimposition of the pre and post treatment STL files. The colors will show the accuracy of the
superimposition, according to the legend on the right. Green denotes precise match between pre- and post-op
models. Blue color means loss andred means gain of tissue contour.
Linear and volumetric measurements were performed to evaluate the dimensional alterations in both groups.
Vertical positional changes of the mid-facial mucosa were performed as follows. Briefly, the models taken at
two time points were superimposed and were trimmed in vestibular area at 10 mm apical to the gingival
margins. Two-Dimensional cross-sections were made in the mesio-distal mid-point of each tooth for mucosal
margin measurements, or the mid-papilla for papilla height change measurements. The distance from the pre-
and post-op outlines were measured in the 2D cross sections to quantify the tissue height changes. (Fig. 4)
11
Fig. 4. Representative images, illustrating measurement of midfacial zenith changes and papillae between pre-
and post-op scanned models. (A) Pre- and 1 year post-operative digital models superimposed, the vertical
yellow line represents the mid-facial site where the 2D cross-section was made. (B) Two-D cross-section
showing the pre- and post-operative mid-facial gingival margins simultaneously. The zenith changes were
measured from plane 1, which was the horizontal line drawn at the level of the pre-operative gingival margin.
(C) Pre- and 1- year post-operative digital models were superimposed, the vertical yellow line represents the
coronal-most position of the papillae. (D) Two-D cross-section showing the superimposed pre- and post-
operative papillae. The vertical papillae changes are measured as the linear distance between pre-operative
and post-operative papillae crests.
Three-dimensional volumetric changes of the facial mucosal tissues was carried out. To that end, a vertical
line, bisecting the pre-operative crown was drawn. A 5-mmx5mm square was defined centered in the vertical
mid-facial line and positioned at the pre-operative gingival margin. (Fig. 6)
Fig. 6. Measurement of 3D volumetric changes of mid-facial tissues. (A) A 5x5mm square region of interest
was defined in the pre-operative mid-facial areas of each model. (B)Tissues outside the square were cropped.
(C) Lateral view of the 3D volume. (D) Volumes were subtracted in order to calculate volume changes.
Horizontal contour changes at 1, 2, 3, 4, 5 mm from the position of gingival margin 1 year after implant
installation: Using the gingival margin of the pre-op model as a reference, planes were drawn at 0, 1, 2, 3, 4, 5
mm. Then, a cross section image was obtained of the superimposed models, and horizontal measurements
were performed following the horizontal planes that were previously drawn (Fig. 7)
12
Fig. 7. Measurement of horizontal tissue contour changes following 1-year post-operative interval following
immediate implant placement. Super-imposition of pre- and post-op models were conducted, followed by
drawing of horizontal planes at 1, 2, 3, 4 and 5mm apical to the pre-op mid-facial gingival margin. (A) Frontal
view of superimposed models with defined horizontal planes and associated cross sections. (2) 2D cross
sectional view and measurement of the horizontal change.
Statistical methods:
The null hypothesis of this study assumed that following the study protocol of flapless extraction, immediate
implant placement with a sloped platform and having a >2mm facial gap only minor peri-implant mucosal
dimensional changes occur. Continuous variables are shown by means of number of subjects analyzed, and
standard deviations. Inter-group comparisons were performed by means of the statistical method of Student´s
t-test. Results were considered being statistically significant when the P-value was ≤0.05.
13
5. Results:
The number of participants that were screened for this randomized controlled clinical trial consisted of 41
subjects. Of these subjects, 2 were excluded. Finally, 39 implants placed in 39 participants were included in
the study. Four subjects dropped out. At 1 year follow up, the study casts for 20 participants were included in
the analysis. (Flowchart, fig. 8)
Fig. 8 Flowchart describing patient screening, allocation, loss and reason for loss.
The mean age of the subjects was 51.76 ± 17.45 in the control group and 65.9 ± 12.52 in the test group. There
were 2 males and 6 females in the control group, and 5 males and 7 females in the test group. All implants
placed were 4.5mm in diameter. Seven implants in the control group were 13 mm long and 1 implant was
15mm long. In the test group, 3 implants were 11 mm long, 6 implants were 13mm long and 3 implants were
15mm long. (Table 2)
14
Table 2. Clinical characteristics of study patients, as well as sites. Demographics, impant dimentions, sites
and participants characteristicis
All patients healed uneventfully, and were restored. However, one subject was excluded due to restoration
beyond the 4-month window after placement.
Vertical positional changes of the mid-facial mucosa:
The mean midfacial mucosal zenith change from the day of tooth extraction and immediate implant placement
to the 1 year follow up visit, was -1.1 ± 0.64 mm (range: 0.66 mm- 2.18 mm) for the control group and -0.82
± 0.53 mm (range: 0.14 mm- 1.74 mm) for the test group. The measurements in the 2 groups was not
statistically significant. (Fig. 8)
Fig. 8. Mean mucosal zenith change in the grafted test (red) and non-grafted control (blue) groups. There
were no statistically differences between the two groups.
Mesial and distal papilla height position change:
The mean mesial papilla loss were 0.89 ± 0.41 mm (range: 0.37 mm – 1.70 mm) and 0.95 ± 0.62 mm (range:
0.16 mm – 2.18 mm) for the control and test groups, respectively. The mean distal papilla loss were 0.84 ±
0.5 mm (range: 0.18 mm – 1.55 mm) and 0.84 ± 0.46 mm (range: 0.40 mm – 2.02 mm) for the control and
test groups, respectively. The differences in the results of the two groups did not reach statistical significance.
(Fig. 9)
15
Fig. 9. Mean mesial and distal papilla loss in the grafted test (red) and non-grafted control (blue) groups.
There were no statistically differences between the two groups..
Horizontal contour changes at 1, 2, 3, 4, 5 mm from the position of the pre-op gingival margin:
In the control group, the mean horizontal dimensional changes at 1, 2, 3, 4, 5 mm relative to the pre-operative
midfacial gingival zenith were -0.62 ± 0.41 mm, -0.74 ± 0.42 mm, -0.71 ± 0.32 mm, -0.71 ± 0.33 mm, -0.76 ±
0.36 mm, respectively. In the test group, the mean horizontal dimensional changes in the same positions were
-0,94 ± 0.48 mm, -0.82 ± 0.63 mm, -0.77 ± 0.61 mm, -0.74 ± 0.53 mm, -0.67 ± 0.51 mm, respectively. There
was no statistically significant difference between the two groups. (Figure 10)
Fig.
10. Mean horizontal dimensional loss at 1, 2, 3, 4, 5 mm. There was no statistically difference between two
groups.
16
3d volumetric changes on the tissues apical to the mucosal zenith:
A 5 mm square area at the midfacial gingival margin was designated as the region of interest and it’s volume
at pre- and post-operative periods were measured. The mean volume loss was 3222 ± 7360 mm
3
and 1313 ±
2563 mm
3
for the control and test group, respectively, with no statistically significant difference between the
two groups. (Fig. 11)
Fig. 11. Changes in the mucosal volume between pre- and post-op. Difference was not statistically significant
different.
17
6. Discussion:
The objective of this multicenter randomized controlled clinical trial was to evaluate whether placement of
bone graft in the facial gap of immediately placed implants in the anterior maxilla influences mucosal
changes. Following the protocol in this study, with careful flapless tooth extraction, implant placement with at
least 2 mm horizontal gap to the facial alveolar bone, implant with sloped platform, only minor mucosal
dimensional changes in soft tissue surface mucosa were observed.
Present study reported a mean vertical soft tissue loss at the mid-facial mucosal zenith one year post
immediate implant placement was 0.92 ± 0.56 mm (range: 2.18 - 0.14 mm). This result is in agreement with
previous published studies (Cordaro et al. 2009, De Rouck et al. 2009). Cordaro et al. 2009, reported that 18
months post extraction and immediate implant placement, a mean buccal mucosal recession of 0.73 mm and
0.82 mm for non-submerged and submerged groups, respectively. No statistically significant difference
between groups was observed. A randomized controlled clinical study (De Rouck et al. 2009) evaluated the
amount of mid-facial apical displacement of the mucosal margin following immediate implants placement.
An average amount of peri-implant mucosal recession after immediate implant with or without immediate
provisional restoration was found to be 0.41 mm and 1.16 mm, respectively. The amount of apical
displacement in submerged implants group was found to be as 2.5 - 3.0 times higher than those in non-
submerged implants group.
A recent systematic review (Chen et al. 2014) concluded that immediate implant placement have a greater
variability of outcomes in the amount of mid facial mucosal recession with recession > 1 mm in 9.0 – 41.0%
of the cases, compared to those of early implant placement.
Despite the fact that in the present study, immediate provisionalization was not performed, only minor mid-
facial recession was observed that was comparable with other studies (Cosyn et al. 2016, Cardaropoli et al.
2015). It has been demonstrated that the immediate provisionalization minimizes the amount of mid-facial
mucosal recession after immediate implant placement by 0.75mm (De Rouck et al. 2009).
Immediate implant placement has been associated with unpredictable alveolar bone resorption, as well as
mid-facial soft tissue recession (Lang et al. 2012). Different factors are believed to play a pivotal role in the
esthetic outcomes, such as integrity and thickness of facial alveolar bone plate, the facial gap between the
implant and the facial plate and the gingival biotype.
The integrity of the facial plate has been considered a prognostic factor influencing mid-facial peri-implant
mucosa level (Lekholm et al. 1996). A prospective clinical study revealed that immediate implant and
provisionalization at site with facial dehiscence showed 34.8% of soft tissue recession (Kan et al. 2007).
Moreover, when a bone defect was present in the mid-facial extending the mesial and distal aspect of the
adjacent teeth, greater than 1.5mm mid-facial recession occurred in 100% of the cases (Kan et al. 2007).
Similar results have been found in another study (Barone et al. 2015).
Secondly, the thickness of the facial bone plate dictates the degree of bone resorption at buccal or facial
aspect for immediate implants. Possible local factors affecting the alveolar ridge remodeling following
immediate implant placement was evaluated and thickness of the buccal plate and the gap between implant to
buccal bone was identified as major factors for alveolar ridge alteration (Ferrus et al. 2010). A thick buccal
bone wall (>1.0 mm) led to the vertical resorption up to 0.4 ± 1.3 mm while a 1.2 ± 2.1 mm of vertical bone
height loss was observed at the buccal thin wall (< 1.0 mm). Lee et al. reported consistent data that a thin
buccal bone plates contribute to significant reduction of the ridge volume (Lee et al. 2014). However, mucosal
changes were not reported in aforementioned studies. A three dimensional study investigated the tissue
dimensional alteration following extraction of maxillary anterior tooth. It was observed that a thin facial bone
wall (< 1.0 mm) leads to significant vertical bone loss of 7.1 mm. On the other hand, less facial bone
destruction was observed at the site with thick buccal bone (Chappuis et al. 2015). These findings are
relevant, as in this situation, existing a deficiency of the facial bone plate present, there is a greater risk of
mid-facial soft tissue recession (Kan et al. 2007). The frequency of thin buccal bone wall (<1.0 mm) was
found in 87% of anterior maxilla tooth. Moreover, CBCT analysis of 250 patients have found similar result,
18
showing that 85% of sites in maxillary anterior have less than 1.0 mm facial plate thickness (Huynh-Ba et al.
2010, Januario et al. 2011). Even with the aid of graft material in the horizontal gap between implant and
facial bone plate, it failed to show the additional benefit of graft when using at the site with thin facial bone
plate at maxillary anterior site. It was concluded that the placement of such a biomaterial did not have an
influence unless the facial bony plate was < 1.0 mm (Sanz et al. 2016). The consideration of the thickness of
the facial bone plate can help clinicians to avoid future soft tissue and esthetic complications.
Thirdly, the gap size between the implant and the facial bone plate has been proved as an influencing factor
for esthetic outcomes by several studies. A prospective clinical study on immediate implants revealed that the
horizontal gap between the implants and the facial bone was the most critical factor affecting bone to implant
contact, as an ingrowth of soft tissue cells was found into the horizontal gap. (Wilson et al. 1998). A study on
immediate implants concluded that when the gap size was > 2.0 mm, the osteointegration at the most coronal
part of the implant was affected, but when the gap was less than 2.0 mm, the amount of osseointegration was
comparable to those in delayed implant. (Paulantonio et al. 2001).
A few years later, Sanz et al. (2010) conducted a clinical trial comparing different geometric type of implant
such as cylindrical and tapered implants placed immediately after tooth extraction. The mean horizontal gap
between the implants and the inner wall of the extraction tooth socket was 2.1 ± 1.1 mm at buccal aspect and
1.1 ± 0.9 mm at the palatal aspects. Post four month implant placement, the gap reduced in a 71% and 66%,
respectively. This study concluded that the gap size is not a critical factor for horizontal bone fill. Another
study conducted by same group supported this finding that the gap size was unrelated and bone formation
behaved similarly when filling the gap with a biomaterial or leaving it unfilled despite the gap size (Sanz et al.
2016).
Lastly, the gingival biotype relation to the prevalence of soft tissue recession have been discussed and still yet
there is no consensus. A prospective clinical study (Kan et al. 2011) assessed the influence of the gingival
biotype in mid facial mucosa level using an immediate implant placement protocol. The result showed less
mid-facial recession (0.56 mm) in sites wtih thick gingival biotype, compared to those with thin biotype (1.50
mm). In contrast, Kesteren et al. failed to demonstrate a significant correlation between gingival biotype and
soft tissue position changes (Kesteren et al. 2010). A prospective study failed to show a correlation between
gingival biotype and soft tissue alterations after immediate implants placement and immediate
provisionalization (Cabello et al. 2012). A retrospective study evaluated the esthetic outcomes, although a
greater amount of soft tissue changes was observed in the thin biotype group, the difference between thin and
thick gingival biotypes was not statistically significant (Evans and Chen 2008).
Immediate implant placement has been associated with greater frequency of loss of papilla height (Lang et al.
2012). In the present study, all participants exhibited only minimal dimensional papilla loss. The mean linear
change of 0.93 ± 0.53 mm and 0.84 ± 0.46 mm were observed in the mesial and the distal papillae,
respectively, for all groups. The mesial papilla loss was 0.89 ± 0.41 mm, and the distal papilla loss was 0.84 ±
0.5 mm for the control group. For the test group, the mesial papilla loss was 0.95 ± 0.62 mm, and the distal
papilla loss was 0.84 ± 0.46 mm, being these results not statistically significant different between groups. The
findings in this study are consistent with other studies that have been published previously. A randomized
clinical trial reported a papilla loss after immediate implant placement one year post treatment. In the control
group, with a delayed restoration placement approach, it was seen a mean papilla loss of 0.53 mm and 0.43
mm, and in the immediate restoration group, the mean papilla loss was 0.31 mm and 0.44 mm for the distal
and mesial papillae, respectively (De Rouck et al. 2009). Another randomized controlled study (Kesteren et
al. 2010) compared immediate and delayed implant placement protocols. The mean interproximal soft tissue
position change was 1.73 ± 0.71 mm for the mesial and 1.48 ± 0.80 mm for the distal, being results were not
statistically significant different between the groups.
A prospective trial (Juodzbalys et al. 2007) looked at the effects of immediate implants with conventional
restoration placement on papilla height change, according to Jemt et al. 1997 index, it was seen that 64.3% of
the papillae analyzed had a score of 2, meaning that the papilla doesn´t fill the interdental space all the way to
the contact point, and 35.7% had a score of 3, meaning that the papilla fill is all the way to the contact point.
Therefore, papilla loss was observed in almost 2/3 of the participants of the study. Different factors will
influence the amount of papilla fill, such as the height of the contact point(Tarnow et al. 1992), crown tooth
shape (Chen et al. 2010), the gingival biotype (Kan et al. 2003), the level of the interproximal bone (Grunder
et al. 2005), that will suffer some remodeling after tooth extraction and after 1 year from the time of implant
19
placement, the attachment to the adjacent tooth (Choquet 2001, Salama H et al. 1998, Grunder et al. 2000),
that can be influenced by the extraction protocol used, the presence of periodontitis etc.A marked resorption
of the ridge of the anterior maxilla can cause an esthetic complication, therefore studying the horizontal
changes after immediate implant placement and the influence of bone graft on the facial gap, can be valuable
to clinicians. In this study, the horizontal loss of surface contour in the crestal 5mm ranged from 0.24 to 1.25
mm and 0.11 to 1.49 mm in the control and test groups, respectively. These results were not statistically
significant different between the groups. The relatively small alterations in the horizontal soft tissue contour
are encouraging.
When we consider the available literature, no studies have reported horizontal changes of soft tissue contour.
The variability in terms of reference points in the different studies that have looked at the horizontal changes,
and the fact that most of the studies either look at the bone or the soft tissue horizontal changes makes
challenging to contrast our result with the available evidence. But several studies have looked at the reduction
that happens at 1 specific point in the ridge. A recent study (cardaropoli et al. 2014) looked at the ridge
reduction on patients treated with immediate implants after 1 year, in the control group the facial gap was left
unfilled, but in the test group the gap was filled with a xenograft. The ridge dimensions were measured at 1
point in stone casts, the means being 0.69mm and 1.92 for the test and control respectively. These results are
comparable to the findings obtained from this study, but we have to take into account that Cardaropoli looked
at the overall ridge reduction, but we looked at the facial ridge reduction.
A systematic review and meta-analysis was conducted to quantify the dimensional changes after tooth
extraction and immediate implant placement (Lee et al. 2014). They were unable to show statistically
significant difference in terms of buccal bone dimensional reduction when a bone graft or a barrier was used.
The difference between groups was 0.53 mm, being the amount of reduction 0.79mm for the non-graft group
and 1.32mm for the non-graft group. These results when compared to this study are comparable.
No studies have reported 3-dimentional changes of soft tissue contour following immediate implant
placement. One of the difficulties in examining 3D alterations is the variability of teeth and their tissue
contour with regard to size and shape. This will make it impossible to compare changes among different teeth.
We circumvented this problem by sampling a 5x5 mm
2
, as a region of interest to monitor 3D contour changes.
Some studies have looked at the dimensional changes that occur when placing either a xenograft or allograft
in the facial gap at immediately placed implants. (Araujo et al. 2011, Sanz et al. 2016, Tarnow et al. 2014)
being all the measurement done either at the time of implant placement elevating a flap or with a caliper on
casts. These methods can be considered to have some limitations, that could be counteracted by using a digital
measuring protocols. Therefore, the use of a pair-wise superimposition software may help to decrease the
amount of error that could happen when using free hand measuring tools.
In the present study, no significant differences were observed between groups with or without bone graft in
the facial gap. It is important to note that the particular implant used in the present study had a sloped
platform (Noelken et al. 2014, 2016, Schiegnitz et al. 2016). Whether the particular sloped platform design
may have contributed to the stability of tissues in both group remains to be investigated.
Some of the limitations of study, include 1) relatively small sample size, 2) patient related influencing factors
not taken into account, such as the gingival biotype or facial bone plate thickness, 3) the unavoidable
volumetric errors in the final digital models that may have been introduced, these can happen at the time of
taking and pouring the impressions or scanning the models, 4) restoration related influencing factors, such as
crown contour or height of proximal contacts.
These conclusions are in agreement with the results obtained by Clementini et al. (2015) in a systematic
review and meta-analysis published. 11 human studies were included in this meta-analysis, but in regards to
the benefit of using regenerative biomaterials at time of immediate implant placement they were inconclusive.
An animal study conducted by Araujo and Lindhe (2009), looked at the thickness of the buccal bone at the
marginal termination of the rough surface of the implant, and 1 mm, 2 mm and 3 mm apical to it. In all these
measurement, the thickness in the test group was greater than in the control group, concluding that there is a
benefit of using a xenograft in the buccal gap between the implant and the buccal plate. A clinical trial
recently published (Sanz et al. 2016), also looked at the influence of using a xenograft in the facial gap at
20
immediately placed implants. A positive influence of filling the gap with a biomaterial was only seen, when
the facial plate was <1mm.
In conclusion, the results from this randomized controlled clinical trial have shown that following the study
protocol of flapless extraction, immediate implant placement with a sloped platform and having a >2mm
facial gap only minor peri-implant mucosal dimensional changes occurred. Furthermore, the addition of
xenograft in the facial gap was not shown to influence the magnitude of tissue contour alterations following
extraction and immediate implant placement. A randomized controlled clinical trial with larger sample size
will be warranted.
21
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Abstract (if available)
Abstract
Introduction: Following extraction of an anterior maxillary tooth and immediate implant placement, complications can arise due to the changes that occur in the periodontal tissues. The aim of this randomized controlled clinical trial was to evaluate whether placement of bone graft in the facial gap at immediately placed implants in the anterior maxilla influences the position of the mid-facial mucosal zenith. ❧ Methods: Patients with a need for a single-tooth replacement in the anterior maxilla, were enrolled in this study. Following tooth extraction, implants with sloped platform (Astra Tech Osseospeed Tx Profile) were placed into the extraction sockets without flap elevation. Randomly assigned experimental sites received anorganic bovine bone mineral (ABBM) in the facial gap, while the gap in control sites were left unfilled. Impressions were obtained at baseline and one year after the date of implantation. Dental stone casts were optically scanned and STL files were imported into reverse engineering software (Geomagic Control) for 3D quantitative analysis. Linear and volumetric measurements were performed to evaluate the dimensional alterations, including positional changes of the mid-facial mucosal zenith, the mesial and distal papilla height position change, 3D volumetric changes on the tissues apical to the mucosal zenith as well as horizontal contour changes at 1, 2, 3, 4, 5 mm from the position of the pre-operative gingival margin. ❧ Results: Patients in both test and control group healed uneventfully after implant placement. The mean mucosal zenith change in the grafted and non-grafted groups were 0.82 ± 0.53 mm and −1.1 ± 0.64 mm, respectively. There were no statistically differences between two groups. The mean mesial papilla loss loss were 0.89 ± 0.41 mm and 0.95 ± 0.62 mm for the control and test groups, respectively. The mean distal papilla loss were 0.84 ± 0.5 mm and 0.84 ± 0.46 mm for the control and test groups, respectively. These results were not statistically significant different. In the control group, the mean horizontal dimensional changes at 1, 2, 3, 4, 5 mm relative to the pre-operative midfacial gingival zenith were −0.62 ± 0.41 mm, −0.74 ± 0.42 mm, −0.71 ± 0.32 mm, −0.71 ± 0.33 mm, −0.76 ± 0.36 mm, respectively. In the test group, the mean horizontal dimensional changes in the same positions were −0,94 ± 0.48 mm, −0.82 ± 0.63 mm, −0.77 ± 0.61 mm, −0.74 ± 0.53 mm, −0.67 ± 0.51 mm, respectively. There was no statistically difference between two groups. The mean volume loss was 3222 ± 7360 mm3 and 1313 ± 2563 mm3 for the control and test group respectively, this difference was not statistically significant different. ❧ Conclusions: The results of this study demonstrated that, when utilizing the particular protocol of this study with careful flapless tooth extraction, implant placement with at least 2mm horizontal gap to the facial alveolar bone, implant with sloped platform, only minor mucosal dimensional changes in soft tissue surface mucosa were observed. The addition of ABBM in the horizontal gap of the socket failed to show the positive influence in the outcome of the facial peri-implant surface mucosa.
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Asset Metadata
Creator
Ceballos Gavilán, Ramón
(author)
Core Title
3D volumetric changes of tissue contour after immediate implant placement with and without xenograft in the horizontal gap: a randomized controlled clinical trial
School
School of Dentistry
Degree
Master of Science
Degree Program
Craniofacial Biology
Publication Date
07/22/2017
Defense Date
06/19/2017
Publisher
University of Southern California
(original),
University of Southern California. Libraries
(digital)
Tag
anterior maxillary implants,facial gap,immediate implants,implants,OAI-PMH Harvest,sloped platform
Language
English
Contributor
Electronically uploaded by the author
(provenance)
Advisor
Chen, Casey (
committee member
), Paine, Michael (
committee member
), Zadeh, Homayoun (
committee member
)
Creator Email
ramon@ortodonciaceballos.com,rceballo@usc.edu
Permanent Link (DOI)
https://doi.org/10.25549/usctheses-c40-409024
Unique identifier
UC11264119
Identifier
etd-CeballosGa-5589.pdf (filename),usctheses-c40-409024 (legacy record id)
Legacy Identifier
etd-CeballosGa-5589.pdf
Dmrecord
409024
Document Type
Thesis
Rights
Ceballos Gavilán, Ramón
Type
texts
Source
University of Southern California
(contributing entity),
University of Southern California Dissertations and Theses
(collection)
Access Conditions
The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the a...
Repository Name
University of Southern California Digital Library
Repository Location
USC Digital Library, University of Southern California, University Park Campus MC 2810, 3434 South Grand Avenue, 2nd Floor, Los Angeles, California 90089-2810, USA
Tags
anterior maxillary implants
facial gap
immediate implants
implants
sloped platform