Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession
NCT ID: NCT04082130
Last Updated: 2021-01-12
Study Results
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Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2019-08-25
2020-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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(XCM)+(CAF)
Surgical protocol for test treatment with CAF + XCM:
After local anesthetizing the recipient site,CAF elevation will be done using (De Sanctis \& Zucchelli 2007) design.Horizontal incisions will be done at the recession site,another two slightly divergent vertical incisions will be done at the end of previous incisions extending to the mucogingival junction.The resulting flap will be split thickness in the surgical papillae area,then will be full thickness exposing 3-4 mm of the bone apically of the dehiscence and after that it will be split thickness in the apical direction,all the muscle insertions will be eliminated,the root surface will be prepared by curettes and chemically treated with 24% EDTA gel.De-epithelialization of the interdental papillae will be done.The XCM will be trimmed and fix onto the root surface 1-2mm coronally of the CEJ using absorbable sutures,and the flap will be coronally advanced to fully cover the XCM and then sutured to the de-epithelialized papillae.
(XCM)+(CAF)
The description of this intervention has been already given before.
(SCTG)+(CAF)
The surgical protocol in the control group will be identical with test group protocol with these exceptions:
1. The entire flap will be elevated as split thickness instead of split-full-split thickness flap.
2. A SCTG harvested from the palate will be used to cover the exposed denuded root surface in lieu of placement of XCM in the test group. And absorbable sutures will be used to stabilize it 2 mm coronally from the CEJ.
3. As in the test group the mucosal flap will coronally advanced to completely cover the SCTG then sutured to the de-epithelialized papillae.
(SCTG)+(CAF)
The description of this intervention has been already given before.
Interventions
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(XCM)+(CAF)
The description of this intervention has been already given before.
(SCTG)+(CAF)
The description of this intervention has been already given before.
Eligibility Criteria
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Inclusion Criteria
* No contraindications for periodontal surgery.
* Presence of one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I defects (Miller 1985).
* The cemento-enamel junction (CEJ) is visible in the defective teeth.
* All patients demonstrating good plaque control.
* No previous periodontal surgery in the targeted area.
Exclusion Criteria
* pregnant or nursing patients.
* history of malignancy, radiotherapy, or chemotherapy.
* Patients taking medications that affect mucosal healing.
* Patients with allergy to collagen.
* Previous participation in a clinical trial.
* Type-1 diabetes patients.
* Patient who have diseases that affect connective tissue metabolism.
18 Years
47 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Noor Alhuda Ewaz Ali, DDS
Role: PRINCIPAL_INVESTIGATOR
MSc student in Periodontics, University of Damascus Dental School
Suleiman Dayoub, DDS MSc PhD
Role: STUDY_CHAIR
Professor of Periodontics, University of Damascus Dental School
Mohammad Alharissy, DDS MSc PhD
Role: STUDY_DIRECTOR
Assistant Professor of Periodontics, Academic Staff Member At Wadi International University
Locations
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Department of Periodontics, University of Damascus Dental School
Damascus, Syrian Arab Republic, Syria
Countries
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References
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Kim HJ, Chang H, Kim S, Seol YJ, Kim HI. Periodontal biotype modification using a volume-stable collagen matrix and autogenous subepithelial connective tissue graft for the treatment of gingival recession: a case series. J Periodontal Implant Sci. 2018 Dec 27;48(6):395-404. doi: 10.5051/jpis.2018.48.6.395. eCollection 2018 Dec.
Matoh U, Petelin M, Gaspersic R. Split-Mouth Comparison of Coronally Advanced Flap with Connective Tissue Graft or Collagen Matrix for Treatment of Isolated Gingival Recessions. Int J Periodontics Restorative Dent. 2019 May/Jun;39(3):439-446. doi: 10.11607/prd.3562.
Jepsen K, Stefanini M, Sanz M, Zucchelli G, Jepsen S. Long-Term Stability of Root Coverage by Coronally Advanced Flap Procedures. J Periodontol. 2017 Jul;88(7):626-633. doi: 10.1902/jop.2017.160767. Epub 2017 Mar 17.
Lafzi A, Abolfazli N, Faramarzi M, Eyvazi M, Eskandari A, Salehsaber F. Clinical comparison of coronally-advanced flap plus amniotic membrane or subepithelial connective tissue in the treatment of Miller's class I and II gingival recessions: A split-mouth study. J Dent Res Dent Clin Dent Prospects. 2016;10(3):162-8. doi: 10.15171/joddd.2016.026. Epub 2016 Aug 17.
Rasperini G, Acunzo R, Pellegrini G, Pagni G, Tonetti M, Pini Prato GP, Cortellini P. Predictor factors for long-term outcomes stability of coronally advanced flap with or without connective tissue graft in the treatment of single maxillary gingival recessions: 9 years results of a randomized controlled clinical trial. J Clin Periodontol. 2018 Sep;45(9):1107-1117. doi: 10.1111/jcpe.12932. Epub 2018 Aug 20.
Stefanini M, Jepsen K, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M, Jepsen S, Zucchelli G. Patient-reported outcomes and aesthetic evaluation of root coverage procedures: a 12-month follow-up of a randomized controlled clinical trial. J Clin Periodontol. 2016 Dec;43(12):1132-1141. doi: 10.1111/jcpe.12626. Epub 2016 Nov 7.
Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.
Stefanini M, Zucchelli G, Marzadori M, de Sanctis M. Coronally Advanced Flap with Site-Specific Application of Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recessions: A 3-Year Follow-Up Case Series. Int J Periodontics Restorative Dent. 2018 Jan/Feb;38(1):25-33. doi: 10.11607/prd.3438.
Tatakis DN, Trombelli L. Gingival recession treatment: guided tissue regeneration with bioabsorbable membrane versus connective tissue graft. J Periodontol. 2000 Feb;71(2):299-307. doi: 10.1902/jop.2000.71.2.299.
Chambrone L, de Castro Pinto RCN, Chambrone LA. The concepts of evidence-based periodontal plastic surgery: Application of the principles of evidence-based dentistry for the treatment of recession-type defects. Periodontol 2000. 2019 Feb;79(1):81-106. doi: 10.1111/prd.12248.
Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.
de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
Other Identifiers
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UDDS-Perio-01-2019
Identifier Type: -
Identifier Source: org_study_id
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