Comparison of Three Transmucosal Augmentation Techniques in Immediate Implant Placement
NCT ID: NCT06820489
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
54 participants
INTERVENTIONAL
2025-04-01
2031-11-01
Brief Summary
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Successful regeneration (primary outcome) is achieved when the combination of socket grafting and transmucosal augmentation (C-CTG or S-CTG or DZ) would be able to counteract any buccal soft tissue loss at level -1 mm. It is assessed on the basis of superimposed CBCTs taken pre-operatively and at one-year follow-up. Secondary outcomes include: horizontal buccal bone loss, vertical buccal bone loss, increase in buccal soft tissue thickness, patient-reported outcomes, plaque, bleeding on probing, probing depth, marginal bone loss, change in buccal soft tissue profile, midfacial soft tissue level, mesial and distal papilla level, Pink Esthetic Score.
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Detailed Description
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Eligible participants are adults with good oral hygiene and an anterior maxillary tooth requiring extraction with adequate bone support. Exclusion criteria include pregnancy, systemic disease, smoking, active infection, periodontal disease, and extensive gingival asymmetry. Fifty-four patients will be randomized equally to the three intervention groups; allocation is concealed and outcome assessors are blinded.
All patients receive immediate implant placement with socket grafting. The three groups differ only in the soft-tissue augmentation method: C-CTG involves placing a connective tissue graft in a buccal pouch; S-CTG uses a smaller graft fixed at the transmucosal aspect without a pouch; DZ relies on graft condensation beneath the soft tissue without a connective tissue graft. Standard postoperative care is provided in all groups.
Hard- and soft-tissue changes are assessed using cone-beam CT, clinical measurements, intra-oral scans, and standardized photography at baseline and follow-up visits. Successful regeneration is defined by maintenance of buccal soft tissue at the specified reference level. Patient-reported postoperative pain and analgesic use are recorded after one week. Esthetic outcomes are evaluated using a validated scoring system at 1- and 5-year follow-up.
Data will be analyzed using appropriate statistical tests for group comparisons, including mixed models for tissue changes, Fisher's exact test for the primary outcome, and non-parametric tests for variables that are not normally distributed. A two-sided significance level of 5% is applied throughout.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Conventional connective tissue graft
Connective tissue graft immediately inserted in buccal pouch
Conventional connective tissue graft after immediate implant placement
A pouch is made in the buccal mucosa extending 3 mm below the buccal bone crest. Thereupon, a free gingival graft is harvested from the palatal mucosa and de-epithelialized. The CTG is brought into the pouch and fixed with two single sutures onto the buccal mucosa. A healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Sutures are removed 1 week after the surgery.
Scarf connective tissue graft
Connective tissue graft immediately fixed onto the buccal mucosa.
Scarf connective tissue graft after immediate implant placement
No pouch is made in the recipient site. A free gingival graft is harvested from the palatal mucosa and de-epithelialized. The small CTG is fixed at the transmucosal aspect onto the buccal mucosa. A healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Sutures are removed 1 week after the surgery.
Dual zone concept
Bone material condensed up to the buccal soft tissue margin.
Dual zone concept after immediate implant placement
DBBM is applied and condensed up to the level of the buccal soft tissue margin. A healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Usually, sutures are not needed in this group, unless minimal papilla opening was required to extract the tooth. In that case, sutures will be removed after 1 week.
Interventions
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Conventional connective tissue graft after immediate implant placement
A pouch is made in the buccal mucosa extending 3 mm below the buccal bone crest. Thereupon, a free gingival graft is harvested from the palatal mucosa and de-epithelialized. The CTG is brought into the pouch and fixed with two single sutures onto the buccal mucosa. A healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Sutures are removed 1 week after the surgery.
Scarf connective tissue graft after immediate implant placement
No pouch is made in the recipient site. A free gingival graft is harvested from the palatal mucosa and de-epithelialized. The small CTG is fixed at the transmucosal aspect onto the buccal mucosa. A healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Sutures are removed 1 week after the surgery.
Dual zone concept after immediate implant placement
DBBM is applied and condensed up to the level of the buccal soft tissue margin. A healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Usually, sutures are not needed in this group, unless minimal papilla opening was required to extract the tooth. In that case, sutures will be removed after 1 week.
Eligibility Criteria
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Inclusion Criteria
* Good oral hygiene defined as full-mouth plaque score ≤ 25%
* Presence of an incisor, cuspid or premolar in the maxilla that needs to be extracted for any reason with at least one neighboring tooth present
* At least 3 mm bone available at the apical or palatal aspect of the alveolus as assessed on CBCT to ensure primary implant stability
* Intact buccal bone wall (type I) or limited buccal bone dehiscence (type IIa or IIb) at the time of extraction
* Written informed consent.
Exclusion Criteria
* Systemic diseases
* Smoking; suppuration
* \> 1 mm gingival asymmetry between the failing and contralateral tooth
* Untreated periodontal disease
* Untreated caries lesions.
20 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
Responsible Party
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Locations
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Ghent University Hospital
Ghent, East Flanders, Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Chu SJ, Salama MA, Salama H, Garber DA, Saito H, Sarnachiaro GO, Tarnow DP. The dual-zone therapeutic concept of managing immediate implant placement and provisional restoration in anterior extraction sockets. Compend Contin Educ Dent. 2012 Jul-Aug;33(7):524-32, 534.
Botticelli D, Berglundh T, Lindhe J. Hard-tissue alterations following immediate implant placement in extraction sites. J Clin Periodontol. 2004 Oct;31(10):820-8. doi: 10.1111/j.1600-051X.2004.00565.x.
Zuiderveld EG, van Nimwegen WG, Meijer HJA, Jung RE, Muhlemann S, Vissink A, Raghoebar GM. Effect of connective tissue grafting on buccal bone changes based on cone beam computed tomography scans in the esthetic zone of single immediate implants: A 1-year randomized controlled trial. J Periodontol. 2021 Apr;92(4):553-561. doi: 10.1002/JPER.20-0217. Epub 2020 Sep 11.
Wanis RW, Hosny MM, ElNahass H. Clinical evaluation of the buccal aspect around immediate implant using dual zone therapeutic concept versus buccal gap fill to bone level: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2022 Jun;24(3):307-319. doi: 10.1111/cid.13091. Epub 2022 May 4.
Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.
Slagter KW, Meijer HJA, Hentenaar DFM, Vissink A, Raghoebar GM. Immediate single-tooth implant placement with simultaneous bone augmentation versus delayed implant placement after alveolar ridge preservation in bony defect sites in the esthetic region: A 5-year randomized controlled trial. J Periodontol. 2021 Dec;92(12):1738-1748. doi: 10.1002/JPER.20-0845. Epub 2021 Apr 3.
Sicilia-Felechosa A, Pereira-Fernandez A, Garcia-Lareu J, Bernardo-Gonzalez J, Sicilia-Blanco P, Cuesta-Fernandez I. Flapless immediate implant placement and provisionalization in periodontal patients: A retrospective consecutive case-series study of single-tooth sites with dehiscence-type osseous defects. Clin Oral Implants Res. 2020 Mar;31(3):229-238. doi: 10.1111/clr.13559. Epub 2020 Jan 20.
Seyssens L, Eghbali A, Cosyn J. A 10-year prospective study on single immediate implants. J Clin Periodontol. 2020 Oct;47(10):1248-1258. doi: 10.1111/jcpe.13352. Epub 2020 Sep 2.
Seyssens L, Eeckhout C, Cosyn J. Immediate implant placement with or without socket grafting: A systematic review and meta-analysis. Clin Implant Dent Relat Res. 2022 Jun;24(3):339-351. doi: 10.1111/cid.13079. Epub 2022 Mar 21.
Seyssens L, De Lat L, Cosyn J. Immediate implant placement with or without connective tissue graft: A systematic review and meta-analysis. J Clin Periodontol. 2021 Feb;48(2):284-301. doi: 10.1111/jcpe.13397. Epub 2020 Nov 20.
Raghoebar GM, Korfage A, Meijer HJA, Gareb B, Vissink A, Delli K. Linear and profilometric changes of the mucosa following soft tissue augmentation in the zone of aesthetic priority: A systematic review and meta-analysis. Clin Oral Implants Res. 2021 Oct;32 Suppl 21:138-156. doi: 10.1111/clr.13759.
O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
Mareque S, Castelo-Baz P, Lopez-Malla J, Blanco J, Nart J, Valles C. Clinical and esthetic outcomes of immediate implant placement compared to alveolar ridge preservation: a systematic review and meta-analysis. Clin Oral Investig. 2021 Aug;25(8):4735-4748. doi: 10.1007/s00784-021-03986-6. Epub 2021 Jun 7.
Kan JYK, Yin S, Rungcharassaeng K, Zucchelli G, Urban I, Lozada J. Facial implant gingival level and thickness changes following maxillary anterior immediate tooth replacement with scarf-connective tissue graft: A 4-13-year retrospective study. J Esthet Restor Dent. 2023 Jan;35(1):138-147. doi: 10.1111/jerd.12996. Epub 2022 Dec 13.
Griffin TJ, Cheung WS, Zavras AI, Damoulis PD. Postoperative complications following gingival augmentation procedures. J Periodontol. 2006 Dec;77(12):2070-9. doi: 10.1902/jop.2006.050296.
Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
Fettouh AIA, Ghallab NA, Mina NA, Abdelmalak MS, Abdelrahman AAG, Shalaby AF, Shemais N. Hard and soft tissue alterations using dual-zone concept versus connective tissue graft at maxillary immediate implant placement: A 1-year randomized clinical and volumetric trial. Clin Oral Implants Res. 2024 May;35(5):510-525. doi: 10.1111/clr.14247. Epub 2024 Feb 19.
Elaskary A, Ghallab N, Thabet A, Shemais N. The bone shielding versus dual-zone concept in treating thin-walled fresh extraction sockets with immediate implant placement: Soft and hard tissue changes. A randomized clinical trial. Clin Implant Dent Relat Res. 2024 Feb;26(1):66-77. doi: 10.1111/cid.13275. Epub 2023 Sep 5.
Cosyn J, Struys T, Van Hove PJ, De Buyser S, De Bruyckere T. A Randomized Controlled Trial on the Timing of Soft-Tissue Augmentation in Immediate Implant Placement: Hard-Tissue Changes and Clinical Outcome. J Clin Periodontol. 2024 Nov;51(11):1534-1544. doi: 10.1111/jcpe.14060. Epub 2024 Sep 1.
Cosyn J, De Lat L, Seyssens L, Doornewaard R, Deschepper E, Vervaeke S. The effectiveness of immediate implant placement for single tooth replacement compared to delayed implant placement: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:224-241. doi: 10.1111/jcpe.13054.
Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. J Clin Periodontol. 2005 Jun;32(6):645-52. doi: 10.1111/j.1600-051X.2005.00726.x.
Assaf JH, Assaf DD, Antoniazzi RP, Osorio LB, Franca FM. Correction of Buccal Dehiscence During Immediate Implant Placement Using the Flapless Technique: A Tomographic Evaluation. J Periodontol. 2017 Feb;88(2):173-180. doi: 10.1902/jop.2016.160276. Epub 2016 Sep 13.
Related Links
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FDA (2023) Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products. Guidance for Industry.
Other Identifiers
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ONZ-2024-0529
Identifier Type: -
Identifier Source: org_study_id
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