Clin Implant Dent Rel Res - 2023 - Amorfini - Implant Rehabilitation of The Esthetic Area A Five Year Retrospective S
Clin Implant Dent Rel Res - 2023 - Amorfini - Implant Rehabilitation of The Esthetic Area A Five Year Retrospective S
DOI: 10.1111/cid.13200
ORIGINAL ARTICLE
1
Private Practice, Gallarate, Italy
2
Department of Surgical Sciences and
Abstract
Integrated Diagnostics (DISC), University of Introduction: To compare the clinical outcomes of anterior single maxillary implants
Genoa, Ospedale S. Martino, L. Rosanna Benzi
10, Genoa, 16132, Italy
placed using conventional or guided implant surgery.
3
Department of Biomedical Sciences, Surgery Methods: In this retrospective clinical study 44 patients rehabilitated with a single
and Dentistry, University of Milan, Milan, Italy
anterior implant in the maxillary arch were included. Twenty-four implants were
4
Division of Prosthodontics and Implant
inserted applying a guided surgery approach (GS), and 20 applying a conventional
Prosthodontics, Department of Surgical
Sciences and Integrated Diagnostics (DISC), freehand approach (CS). Outcome measures were: implant survival rate and compli-
University of Genoa, Ospedale S. Martino,
cations; mean bone level (MBL) evaluated at surgery (T0), after 6 weeks (6 W), and
L. Rosanna Benzi 10, Genoa, 16132, Italy
after 1 year (1Y), 2 years (2Y), 3 years (3Y), 4 years (4Y), and 5 years (5Y); patients'
Correspondence
Leonardo Amorfini, Via Postporta, 2, 21013
satisfaction evaluated through a questionnaire filled out before surgery (BS) and at
Gallarate VA, Italy. 1 week, 6 W, 2Y and 5Y; Pink esthetic score (PES) and white esthetic score (WES)
Email: [email protected]
evaluated at 1Y, 3Y and 5 Y. Significance of differences between groups were tested
by Fisher's exact test, Mann–Whitney U test, and Wilcoxon's signed rank test.
Results: During the 5-year follow-up there were no drop-outs and no implant failed.
No significant differences between groups were found in MBL. A significant differ-
ence between groups was found in VAS scores regarding speech at 2 years, aes-
thetics at 6 weeks, confidence at 1 week and 6 weeks, satisfaction at T0 and at 1 W,
pain/comfort at 1 W and at 6 W; all VAS scores resulted significantly improved com-
pared to baseline. No significant differences in WES were found, while significant dif-
ferences in PES scores between CS and GS groups were found at 3 and 5 years (p
value = 0.023 and 0.004 respectively) with better outcomes for GS. A significant dif-
ference over time was found in PES between 5-year and one-year values.
Conclusions: Guided surgery and conventional surgery implants did not show any dif-
ference in MBL during the 5-year observation period. Guided surgical procedure guar-
antee optimal esthetic outcome and seems able to guarantee better soft tissue result
over time, even though more long-term studies are necessary to confirm this data.
KEYWORDS
accuracy, bone loss, computer-aided surgery, computer-assisted surgery, dental implants,
esthetic implants, patient satisfaction, postextractive implants
438 © 2023 Wiley Periodicals LLC. wileyonlinelibrary.com/journal/cid Clin Implant Dent Relat Res. 2023;25:438–446.
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AMORFINI ET AL. 439
Summary Box
What is known
• Guided Surgery has limited imprecisions and havebeen demonstrated to be reliable.
Inclusion criteria: Basel, Switzerland) with a diameter between 3.3 and 4.1 mm,
and length between 10 and 14 mm depending on available bone.
• More than 20 years old (Figures 1 and 2).
• Good general health with no contraindications to oral surgery In the CS group a full-thickness flap with minimal vertical releas-
• Single implant inserted in the maxilla ing incisions (not beyond the mucogingival line) was realized to opti-
mize visibility of the alveolar crest.
Exclusion criteria: In this case, the wax-up was modified to allow the passage of the
burs and an appropriate three-dimensional implant insertion. Implants
• Heavy smokers (20 cigarettes/day) placed were the same as for GS group patients.
• Disease of the oral mucosa A minimum torque insertion of 30 Ncm was required to proceed
• Previous radiation therapy of the head and neck area with immediate nonfunctional loading of the implants.
• Necessity of bone regenerative procedures Once the implants were inserted, titanium temporary abut-
• Bruxism ments (Straumann AG, Basel, Switzerland) were screwed on both
• Inadequate oral hygiene CS and GS implants, and 6.0 Vicryl sutures were used to stitch the
flaps.
Before surgery a professional oral hygiene session was executed, Both patient groups received connective tissue graft from the pal-
intra- and extra-oral photographs were taken, and dental impressions ate (Zucchelli technique)28,29 on the buccal aspect of the flap in order
or intraoral scans were collected. Impressions were used to elaborate to minimize the soft tissue contraction during healing phase.
the wax-up representing the ideal shape and position of the definitive The temporary crowns were fabricated by the dental laboratory
prosthesis. Final set-ups for GS Group were duplicated in radio- before surgery in acrylic resin. Immediately after surgery, they were
opaque material before being encapsulated in the scan template adapted to the abutments using light-cure flowable composite resin
(radiographic stent). The material used for the duplication was a mix- Enamel Plus (Micerium, Avegno, Italy).
ture of 10% barium sulphate and 90% acrylic resin, to prevent scatter- Dental dam was used to prevent contamination of the implant
ing artifacts and allow accurate cone beam computed tomography site. Any occlusal contact was avoided. The provisional prosthesis was
(CBCT) imaging of the ideal profile of the final tooth and soft tissues than refined, polished, and screwed on the implant.
(the radio-transparent area between the radio-opaque prosthesis The time required for surgery and for temporary prosthesis instal-
and bone profile). The patients wore the scan template during CBCT lation were registered using a chronometer for both groups.
scans, and the resulting DICOM data were imported into CoDiagnostix Patients were prescribed 600 mg ibuprofen to take on the day
software (Straumann AG, Basel, Switzerland) by the same clinician (LA). of surgery and then as needed for a maximum of 4 days. Patients
All the collected information was sent to the dental laboratory and the were also given 2 g of amoxicillin 1 h before surgery, and then 1 g
dental scan template was transformed into a surgical template by the every 12 hours for 6 days to prevent infection. Patients were
insertion of drill guide sleeves. instructed to clean their temporary prosthesis using a very soft
For the CS Group a wax-up was created and it was used to create brush (Postoperation Curaprox, Basel, Switzerland) for 7 days after
an eggshell resinous provisional crown to be relined immediately after surgery, and to rinse with 0.12% chlorhexidine mouthwash three
surgery. CBCT were executed before surgery using the same device times daily for 15 days. Patients were also advised against biting
(2 Giano Newtom | CEFLA S.C. - IMOLA, Italy). hard foods using the temporary crown for the first 6 weeks
postsurgery.
Sutures were removed 1 week after surgery. Patients were
2.2 | Surgical procedure evaluated 6 and 12 weeks after surgery and then after 1, 2, 3, 4 and
5 years.
Before surgery patients executed a chlorhexidine 0.2% rinse for one Three months after surgery, final impressions (Impregum or
minute. Local anesthesia was performed. Intraroal scan, 3Shape) were taken and the definitive prostheses
In case of postextractive implants, the teeth were gently (screw-retained zirconia-fused-to-porcelain crowns designed by
extracted paying attention to not compromise the vestibular bone. CAD-CAM - Straumann AG, Basel, Switzerland) were screwed on
The alveolus was carefully debrided before preparation of the osteot- the implants.
omy for implant insertion. All single crowns were made using Straumann® Variobase®
In the GS group a tunnel technique was performed in order to screw-retained abutments on which a CAD-CAM zirconia cap was
preserve as much as possible the papillae and the soft tissues and to cemented. The ceramic was fused directly onto the zirconia cap
create the space for a connective tissue graft to be sutured on the before definitive cementation.
buccal aspect of the site. One single experienced dental technician realized all the labora-
The surgical guide was then fitted on the teeth and the bone was tory procedures.
drilled according to the implant manufacturer protocol. The implants Patients were then enrolled in a recall program including a profes-
used were Bone Level Tapered, SLActive, Roxolid (Straumann AG, sional oral hygiene session at least every 6 months.
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AMORFINI ET AL. 441
FIGURE 1 Guided surgery intervention. Intraoral pictures and radiographic control immediately after implant placement.
TABLE 1 VAS scores of all patients before surgery (BS), at 1 week (1 W), 6 weeks (6 W), 2 years (2Y), and at 5 years (5Y)
VAS speech
Mann–Whitney Wilcoxon's
Time-point GS CS GS CS GS CS GS CS U test signed-rank test
BS 8.12 7.70 0.85 0.80 8.00 8.00 [6.00, 10.00] [6.00, 9.00] 0.085 —
1W 8.38 8.35 0.65 0.75 8.00 8.00 [7.00, 10.00] [7.00, 10.00] 0.947 < 0.001
6W 7.79 7.70 0.83 0.73 8.00 8.00 [6.00, 10.00] [7.00, 9.00] 0.653 0.191
2Y 9.42 8.95 0.58 0.51 9.00 9.00 [8.00, 10.00] [8.00, 10.00] 0.008 < 0.001
5Y 9.46 9.20 0.59 0.41 9.50 9.00 [8.00, 10.00] [9.00, 10.00] 0.076 < 0.001
VAS function
Mann–Whitney Wilcoxon's
Time-point GS CS GS CS GS CS GS CS U test signed-rank test
BS 6.08 5.95 0.72 0.94 6.00 6.00 [5.00, 8.00] [5.00, 8.00] 0.383 —
1W 7.08 6.80 0.65 0.83 7.00 7.00 [6.00, 8.00] [5.00, 8.00] 0.245 <0.001
6W 8.12 7.80 0.80 0.62 8.00 8.00 [6.00, 9.00] [6.00, 9.00] 0.093 <0.001
2Y 9.17 8.90 0.48 0.45 9.00 9.00 [8.00, 10.00] [8.00, 10.00] 0.066 <0.001
5Y 9.17 9.00 0.48 0.32 9.00 9.00 [8.00, 10.00] [8.00, 10.00] 0.182 <0.001
VAS aesthetics
Mann–Whitney Wilcoxon's
Time-point GS CS GS CS GS CS GS CS U test signed-rank test
BS 6.25 6.30 0.79 0.73 6.00 6.00 [5.00, 8.00] [5.00, 7.00] 0.741 —
1W 7.42 7.30 0.83 0.66 7.00 7.00 [6.00, 9.00] [6.00, 9.00] 0.533 <0.001
6W 8.00 6.90 0.51 0.55 8.00 7.00 [7.00, 9.00] [6.00, 8.00] <0.001 <0.001
2Y 9.21 8.90 0.51 0.55 9.00 9.00 [8.00, 10.00] [8.00, 10.00] 0.064 <0.001
5Y 9.21 8.90 0.51 0.55 9.00 9.00 [8.00, 10.00] [8.00, 10.00] 0.064 <0.001
VAS confidence
Mann–Whitney Wilcoxon's
Time-point GS CS GS CS GS CS GS CS U test signed-rank test
BS 5.58 5.50 1.10 0.51 5.00 5.50 [4.00, 9.00] [5.00, 6.00] 0.596 —
1W 6.50 5.10 0.83 0.31 6.00 5.00 [5.00, 9.00] [5.00, 6.00] <0.001 0.0361
6W 7.42 6.70 0.65 0.57 7.00 7.00 [6.00, 9.00] [6.00, 8.00] 0.001 <0.001
2Y 9.17 8.95 0.48 0.51 9.00 9.00 [8.00, 10.00] [8.00, 10.00] 0.157 <0.001
5Y 9.17 9.05 0.48 0.39 9.00 9.00 [8.00, 10.00] [8.00, 10.00] 0.374 <0.001
VAS satisfaction
Mann–Whitney Wilcoxon's
Time-point GS CS GS CS GS CS GS CS U test signed-rank test
BS 8.29 7.35 0.75 0.59 8.00 7.00 [6.00, 9.00] [6.00, 8.00] <0.001 -
1W 8.38 7.60 0.65 0.50 8.00 8.00 [7.00, 9.00] [7.00, 8.00] <0.001 0.0234
6W 8.46 8.20 0.66 0.52 9.00 8.00 [7.00, 9.00] [7.00, 9.00] 0.108 <0.001
2Y 9.21 9.00 0.51 0.32 9.00 9.00 [8.00, 10.00] [8.00, 10.00] 0.111 <0.001
5Y 9.17 9.10 0.48 0.31 9.00 9.00 [8.00, 10.00] [9.00, 10.00] 0.550 <0.001
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AMORFINI ET AL. 443
TABLE 1 (Continued)
VAS pain–comfort
Mann–Whitney Wilcoxon's
Time-point GS CS GS CS GS CS GS CS U test signed-rank test
BS 7.17 6.85 0.96 0.99 7.00 7.00 [4.00, 9.00] [5.00, 8.00] 0.297 —
1W 8.38 7.55 0.58 0.69 8.00 8.00 [8.00, 10.00] [6.00, 9.00] <0.001 <0.001
6W 8.46 7.50 0.59 0.51 8.00 7.50 [8.00, 10.00] [7.00, 8.00] <0.001 <0.001
2Y 9.08 8.85 0.58 0.37 9.00 9.00 [8.00, 10.00] [8.00, 9.00] 0.131 <0.001
5Y 9.21 9.05 0.51 0.22 9.00 9.00 [8.00, 10.00] [9.00, 10.00] 0.175 <0.001
Note: p-values in bold indicate statistically significant differences between GS group and CS group (Mann–Whitney U test column) or between a timepoint
and T0 (Wilcoxon's signed-rank test).
independent examiner. PES and WES were evaluated at 1Y, 3Y, Forty-four implants were evaluated, 24 in the GS group and 20 in the
and 5 Y. CS group. Postextractive implants were 11 (29%) in GS and 4 (20%) in CS
group, the percentage difference between groups was not significant.
As secondary outcomes, the time required for surgery and the The mean follow-up time was 69 months (range: 61–68 months).
time required for provisionalization have been recorded for both pro- All the implants received a provisional nonfunctionally loaded sin-
cedures, and the discrepancy between the final implant position and gle crown immediately after insertion.
the planned position (base and tip three-dimensional position) was No implants failed during the 5-year follow-up resulting in a
evaluated in the GS group using Codiagnostic software (Straumann 100% implant CSR for both groups.
AG, Basel, Switzerland). The null hypothesis tested was not completely rejected. A signifi-
cant difference between groups was found in VAS scores regarding
speech at 2Y, aesthetics at 6 W, confidence at 1 W and 6 W, satisfac-
2.4 | Statistical analysis tion at T0 and at 1 W, pain/comfort at 1 W and 6 W; all VAS scores
resulted significantly improved from baseline (Table 1).
Data were statistically analyzed. Continuous variables were given as MBL recordings were within normal limits and no significant dif-
means with standard deviations (SD) or medians with interquartile ferences between groups were found. A significant difference was
range [IR], whereas categorical variables as number and/or percentage found in MBL recordings between each timepoint and the previous
of subjects. The Fisher's exact test was used to compare the frequen- one (Table 2).
cies of postextractive implants in the two groups. The intergroup VAS No significant differences in WES evaluation were found between
score and MBL recordings comparisons were performed by means of groups nor over time (Table 3). Significant differences between groups
the Mann–Whitney U test, the longitudinal VAS score and MBL were found at 3Y and 5Y in PES values (p value = 0.023 and 0.004
recordings comparisons were performed by the Wilcoxon's signed respectively). A significant difference over time was found in PES
rank test. The Mann–Whitney U test was used also to compare WES, between timepoint 5Y and 1Y (Table 3).
PES, surgery time and provisionalization time values between groups. The median surgery time for the GS was 15.50 min (12.50, 19.75)
The association between the evaluation at 3Y and at 1Y, and between and the median surgery time for the CS was 41.00 min (28.50, 48.00);
5Y and 1Y of WES and PES was tested by the Wilcoxon's signed rank this difference was statistically significant ( p value <0.001). The mean
test. Differences between postextractive and nonpostextractive provisionalization time was 12.00 min (range: 10.00, 15.00) for GS,
implants in Base 3D and Tip 3D were evaluated with the Student's and 30.00 min (range: 20.00, 34.00) for CS; this difference was statis-
t test. tically significant ( p value <0.001). No significant differences were
Differences with a p-value <0.05 were considered significant. found in Base 3D, Tip 3D, WES and PES between postextractive and
Data were acquired and analyzed in R v3.4.4 software environment. nonpostextractive implants (Table 4).
Six implants out of 44 (13%) presented a prosthetic complication
(one case of occlusal screw loosening, three cases of pigmentation of
3 | RESULTS the provisional prosthesis; one case of provisional vestibular hollow
screw, one provisional fracture): one of them belonged to the GS
Twenty-three women and 21 men were treated and mean age of group and five to the CS group; this difference was not statistically
the sample of patients was 54 years (range: 38–74 years). significant. Five implants out of 44 (11%) encountered a surgical com-
10 patients were smokers, 8 patients had previous periodontal plication (need for unexpected GBR); one in the GS group and four in
problems. the CS group, this difference was not statistically significant.
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444 AMORFINI ET AL.
T A B L E 2 MBL recordings (mm) after surgery (T0), at 6 weeks (6 W), 6 months (6 M), 1 year (1Y), 2 years (2Y), 3 years (3Y), 4 years (4Y) and
5 years (5Y).
MBL
Mann–Whitney Wilcoxon's
Time-point GS CS GS CS GS CS GS CS U test signed-rank test
T0 0.20 0.12 0.20 0.17 0.20 0.00 [0.00, 0.50] [0.00, 0.50] 0.214 —
6W 0.24 0.18 0.23 0.20 0.30 0.20 [0.00, 0.60] [0.00, 0.60] 0.400 0.013
6M 0.33 0.26 0.28 0.25 0.35 0.25 [0.00, 0.90] [0.00, 0.80] 0.332 <0.001
1Y 0.38 0.31 0.30 0.27 0.45 0.40 [0.00, 1.00] [0.00, 0.80] 0.371 0.003
2Y 0.47 0.42 0.31 0.30 0.50 0.50 [0.00, 1.00] [0.00, 1.00] 0.488 <0.001
3Y 0.52 0.43 0.34 0.29 0.55 0.50 [0.00, 1.00] [0.00, 1.00] 0.361 0.026
4Y 0.53 0.49 0.32 0.29 0.50 0.50 [0.00, 1.00] [0.00, 1.00] 0.609 0.007
5Y 0.59 0.56 0.36 0.32 0.60 0.50 [0.00, 1.20] [0.00, 1.00] 0.678 0.016
Note: p-values in bold indicate statistically significant differences between GS group and CS groups (Mann–Whitney U test column) or between a
timepoint and the previous one (Wilcoxon's signed-rank test).
Intergroup Intragroup
Total Guided Standard p value p value
N 44 24 20
WES
1Y 9.00 [8.00, 9.00] 9.00 [8.00, 9.00] 9.00 [8.00, 9.00] 0.625 —
3Y 9.00 [8.00, 9.00] 9.00 [8.00, 9.00] 9.00 [8.00, 9.00] 0.625
5Y 9.00 [8.00, 9.00] 9.00 [8.00, 9.00] 8.00 [8.00, 9.00] 0.250 0.072
PES
1Y 8.00 [8.00, 9.00] 8.50 [8.00, 9.00] 8.00 [8.00, 8.25] 0.063 —
3Y 8.00 [8.00, 9.00] 8.50 [8.00, 9.00] 8.00 [7.00, 8.25] 0.023 0.149
5Y 8.00 [8.00, 9.00] 8.00 [8.00, 9.00] 8.00 [7.00, 8.00] 0.004 0.005
Note: Results are expressed as Medians [Interquartile Range]; Intergroup p value = Mann–Whitney test p value; Intragroup p value = Wilcoxon's signed
rank test p value.
4 | DISCUSSION connective tissue graft was used in both groups as proposed by Zuc-
chelli et al28,29 A graft was collected from the patients' palate and
The present study demonstrated that both the CS and GS group after de-epithelialization and removal of fatty tissue was sutured of
reached a good and successful esthetic and functional outcome of the buccal site of the flap.28,29
their implant-supported rehabilitation and both soft and hard tissue In addition, it is worth underlying that the guided surgery approach
resulted stable over time. allows the incision of a flap with a more conservative design or might
Marginal bone level (MBL) recordings did not significantly differ even be combined with flapless surgery, with several advantages.
between the two groups, and the values were within normal limits in The possibility of avoiding flaps in the esthetic area, besides
the medium-term follow-up of the present study. At every time point reducing morbidity in the postoperative period, guarantees better tis-
MBL increased significantly in both groups. The present findings are sue stability and consequently a better esthetic result. In fact, the
slightly better compared to those reported using tissue level implants untouched papillae tend not to recede, and the vestibular margins are
with a convergent collar, where mean bone level changes were less prone to be reabsorbed, while traditional open-flap surgery might
0.81 mm (SD 0.10) at the 3-year follow-up,29 and 0.83 at the 5-year be followed by scar retraction and therefore is associated with a
follow-up.30 In contrast, slightly lower values were reported when greater risk of soft tissue recession and possible blemishes.
MBL of tissue level implants was evaluated at the 5-year follow-up. Limits of the present research must be acknowledged. First of all,
Similar results were also found by Gjevold et al. when they evaluated this is a retrospective analysis on treated cases. Additionally no power
in a randomized clinical trial MBL after 5 years comparing delayed (DL) an analysis was conducted consequently the statistical sample size may
immediate loading (IL) implant in the anterior area of the maxilla. The have introduced possible biases in the results. Further studies with a
MBL values they found for IL and DL implants were 0.50 ± 0.73 mm larger number of patient involved and with long-term follow-up are
(0.45, 2.81) and 0.54 ± 0.65 mm (0.36, 2.37) respectively, and are needed to validate the results emerging from this study.
similar to those of the present report,31 even-though only implant placed
in the esthetic area were included in this report.
The GS procedure showed slightly better results when compared 5 | CONC LU SIONS
to CS. Besides biological and esthetic parameters also other aspects
should be considered such as the time employed for surgery time and GS and CS implants did not show any difference in MBL over time in
for provisionalization. The differences between groups were statisti- the 5-year observation period of the present study.
cally different and they are clinically significant as well since the stan- The guided surgery procedure herein described guaranteed opti-
dard procedures required1 almost a 3-time bigger duration. This can mal esthetic outcomes and seems able to induce better soft tissue
affect both patient and operator perception and comfort. results over time, even though further long-term studies are necessary
Digitally planned prosthodontic position guaranteed a correct to confirm this data.
prosthetically driven implant positioning, allowing a better esthetic Patients showed a better compliance and confidence when treated
result and a long-term maintenance as well. With guided computer with the guided surgery compared with the conventional approach.
programming, the provisional restoration is realized before surgery, on Chair side time was reduced for both surgical and prosthetic pro-
the base of the digitally planned position of the implant. Furthermore, cedures when GS was performed compared to CS, with less surgical
Furthermore, according to our results, greater precision and reduced and prosthodontic complications. The guided surgery technique
time for provisionalization was achieved and less prosthetic complica- recorded a high correspondence between the definitive implant posi-
tions were observed 32. tion and the planned one.
It must be underlined that the accuracy of guided surgery might be
affected by several factors, including the type of support for the surgi- AUTHOR CONTRIBU TIONS
cal template: tooth-supported guides, such as the ones used in the pre- Leonardo Amorfini: data collection, research design, final approval.
sent study for single implant rehabilitations, have demonstrated greater Marco Migliorati: concept/design, analysis of data, drafting the paper
accuracy compared with bone and mucosa-supported guides.16 and final approval. Paolo Pesce: concept/design, drafting the paper,
In addition, higher accuracy was found when the implants were and final approval. Sara Drago: acquisition, drafting the paper and final
placed in bounded edentulous rather than in distal extension spaces.22 approval. Eugenio Romeo: data interpretation, final approval. Sara
These aspects might have affected the optimal outcomes of the Drago: concept/design, data analysis and statistics, final approval.
present research. Maria Menini: concept/design, drafting the paper, and final approval.
Guided surgery showed reliable results in terms of position
achieved by the implant in respect to the planned position and CONFLIC T OF INTER E ST STATEMENT
showed not to be influenced by postextractive sites. The authors declare no conflict of interest
It must be considered that all these procedures were applied in
patients with limited bone reduction, and the socket preservation pro- DATA AVAILABILITY STAT EMEN T
cedure as well as the connective tissue graft on the vestibular side The data that support the findings of this study are available from the
contributed to the optimal esthetic results in both groups. A corresponding author upon reasonable request.
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446 AMORFINI ET AL.