Comparison of Envelope Coronally Advanced Flap and Modified Tunnel Technique in Soft Tissue Dehiscence Around Implants
NCT ID: NCT03498911
Last Updated: 2022-05-09
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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COMPLETED
NA
28 participants
INTERVENTIONAL
2018-07-10
2022-04-11
Brief Summary
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Detailed Description
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1. mean mid-facial recession coverage (mRC) measured as a percentage
2. the keratinized tissue (KT) gain measured in mm
3. the keratinized tissue thickness (KTT) gain measured in mm.
The secondary aims are to compare the two groups in terms of:
1. Esthetic score, using numeric values from 0 to 10
2. patient-reported esthetics, using numeric values from 1 to 5
3. patient-reported post-operative pain, based on Visual Analog Scale (VAS) scale, measured as numbers from 0 to 10.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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envelope Coronally Advanced Flap (eCAF)
A mucogingival surgery where an envelope flap is coronally advanced and sutured to cover the mucosal recession
Mucogingival surgery
The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa
Modified Tunnel Technique (MTT)
A mucogingival surgery where the gingiva is released without reflecting a flap (as described for tunnel techniques) and then coronally advanced and sutured to cover the mucosal recession
Mucogingival surgery
The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa
Interventions
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Mucogingival surgery
The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa
Eligibility Criteria
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Inclusion Criteria
* Periodontally and systemically healthy
* Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
* Correct implant 3-dimensional position or buccal position ≤ 1 mm
* Buccal soft tissue dehiscence ≤ 4 mm
* Only osseointegrated implants
* The patient must be able to perform good oral hygiene
Exclusion Criteria
* Patients pregnant or attempting to get pregnant
* Malpositioned implant
* Soft tissue dehiscence (STD) \> 4 mm
* Multiple adjacent implants with STD
* Existing of peri-implantitis
* Severe bone loss (≥4mm)
* Moderate-severe interproximal bone loss (implant fixture level to the alveolar bone \> 3 mm)
* Moderate-severe papilla height loss (Nordland and Tarnow implant papillae index \>1)
* Previous mucogingival surgery around the implant within the past six months or implant placement at the surgical site less than six months prior
* Smoking more than 10 cigarettes a day
18 Years
ALL
No
Sponsors
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Delta Dental Foundation
OTHER
University of Michigan
OTHER
Responsible Party
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Hom-Lay Wang, DDS, MSD, Ph D
Collegiate Professor of Periodontics and Professor of Dentistry
Principal Investigators
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Hom-Lay Wang, DDS MSD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan School of Dentistry
Ann Arbor, Michigan, United States
Countries
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References
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Zucchelli G, Mazzotti C, Mounssif I, Mele M, Stefanini M, Montebugnoli L. A novel surgical-prosthetic approach for soft tissue dehiscence coverage around single implant. Clin Oral Implants Res. 2013 Sep;24(9):957-62. doi: 10.1111/clr.12003. Epub 2012 Aug 27.
Sculean A, Chappuis V, Cosgarea R. Coverage of mucosal recessions at dental implants. Periodontol 2000. 2017 Feb;73(1):134-140. doi: 10.1111/prd.12178.
Schwarz F, Mihatovic I, Shirakata Y, Becker J, Bosshardt D, Sculean A. Treatment of soft tissue recessions at titanium implants using a resorbable collagen matrix: a pilot study. Clin Oral Implants Res. 2014 Jan;25(1):110-5. doi: 10.1111/clr.12042. Epub 2012 Oct 31.
Roccuzzo M, Gaudioso L, Bunino M, Dalmasso P. Surgical treatment of buccal soft tissue recessions around single implants: 1-year results from a prospective pilot study. Clin Oral Implants Res. 2014 Jun;25(6):641-6. doi: 10.1111/clr.12149. Epub 2013 Apr 15.
Morelli T, Neiva R, Nevins ML, McGuire MK, Scheyer ET, Oh TJ, Braun TM, Nor JE, Bates D, Giannobile WV. Angiogenic biomarkers and healing of living cellular constructs. J Dent Res. 2011 Apr;90(4):456-62. doi: 10.1177/0022034510389334. Epub 2011 Jan 19.
Burkhardt R, Joss A, Lang NP. Soft tissue dehiscence coverage around endosseous implants: a prospective cohort study. Clin Oral Implants Res. 2008 May;19(5):451-7. doi: 10.1111/j.1600-0501.2007.01497.x. Epub 2008 Mar 26.
Bassetti RG, Stahli A, Bassetti MA, Sculean A. Soft tissue augmentation around osseointegrated and uncovered dental implants: a systematic review. Clin Oral Investig. 2017 Jan;21(1):53-70. doi: 10.1007/s00784-016-2007-9. Epub 2016 Nov 21.
Anderson LE, Inglehart MR, El-Kholy K, Eber R, Wang HL. Implant associated soft tissue defects in the anterior maxilla: a randomized control trial comparing subepithelial connective tissue graft and acellular dermal matrix allograft. Implant Dent. 2014 Aug;23(4):416-25. doi: 10.1097/ID.0000000000000122.
Tavelli L, Majzoub J, Kauffmann F, Rodriguez MV, Mancini L, Chan HL, Kripfgans OD, Giannobile WV, Wang HL, Barootchi S. Coronally advanced flap versus tunnel technique for the treatment of peri-implant soft tissue dehiscences with the connective tissue graft: A randomized, controlled clinical trial. J Clin Periodontol. 2023 Jul;50(7):980-995. doi: 10.1111/jcpe.13806. Epub 2023 Apr 4.
Other Identifiers
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HUM00140205
Identifier Type: -
Identifier Source: org_study_id
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