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| Name | Class |
|---|---|
| Delta Dental Foundation | OTHER |
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The purpose of this study is to assess the influence of two different flap designs (envelope Coronally Advanced Flap (eCAF) and Modified Tunnel Technique (MTT)) with the addition of a connective tissue graft (CTG) in treating soft tissue dehiscences at implant sites
The primary aim is to compare the test and control groups in terms of:
The secondary aims are to compare the two groups in terms of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| envelope Coronally Advanced Flap (eCAF) | Active Comparator | A mucogingival surgery where an envelope flap is coronally advanced and sutured to cover the mucosal recession |
|
| Modified Tunnel Technique (MTT) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucogingival surgery | Procedure | The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean mid-facial recession coverage (mRC) | mRC measured as a percentage | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Esthetic score | Esthetic score measured using numeric values from 0 to 10 | 6 months and 1 year |
| Patient-reported esthetics | Patient-reported esthetics measured using numeric values from 1 to 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hom-Lay Wang, DDS MSD PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22924841 | Result | 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. | |
| 28000282 | Result | 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. |
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| 6 months and 1 year |
| Patient-reported post-operative pain | Patient-reported post-operative pain, based on VAS scale, measured as numbers from 0 to 10. | 2 weeks |
| Keratinized tissue (KT) gain | KT gain measured in mm | 6 months and 1 year |
| Keratinized tissue thickness (KTT) | KTT gain measured in mm | 6 months and 1 year |
| 23113567 | Result | 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. |
| 23582029 | Result | 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. |
| 21248359 | Result | 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. |
| 18371102 | Result | 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. |
| 27873018 | Result | 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. |
| 25033346 | Result | 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. |
| 36935199 | Derived | 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. |