Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession

NCT04082130 | Completed DMC

• 1 other identifier: UDDS-Perio-01-2019
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller Class I gingival recessions; and as a split-mouth study design one side will be treated with (SCTG+CAF), while the other will be treated with (XCM+CAF).

Conditions

Gingival Recession Localized Moderate

Keywords

Xenogenic collagen matrix (XCM).; subepithelial connective tissue graft (SCGT).; coronally advanced flap (CAF).; Root coverage.

Outcome Measures

Primary Outcomes (1)

• Recession depth (REC): (Change in the amount of root coverage)

  from the free gingival margin to the cemento-enamel junction at the mid-buccal aspect. Using University of North Carolina periodontal probe UNC15 (Medesey®-Italy).

  1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.

Secondary Outcomes (10)

• change in visible plaque index:

  1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative

• Recession width (RW)

  1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative.

• Width of keratinized tissue (KT)

  1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative.

• Thickness of gingival tissue (GT)

  1) at baseline, and 2) 3 months postoperative.

• Probing depth (PD)

  1) at baseline, 2) and 3 months postoperative.

Study Arms (2)

(XCM)+(CAF)

EXPERIMENTAL

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.

Procedure: (XCM)+(CAF)

(SCTG)+(CAF)

ACTIVE COMPARATOR

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.

Procedure: (SCTG)+(CAF)

Interventions

(XCM)+(CAF) PROCEDURE

The description of this intervention has been already given before.

(XCM)+(CAF)

(SCTG)+(CAF) PROCEDURE

The description of this intervention has been already given before.

(SCTG)+(CAF)

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health.
• 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.

You may not qualify if:

• Smokers.
• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Periodontics, University of Damascus Dental School

Damascus, Syrian Arab Republic, DM20AM18, Syria

Location

Related Publications (12)

• 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.

  PMID: 30619640 BACKGROUND

• 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.

  PMID: 30986293 BACKGROUND

• 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.

  PMID: 28304210 BACKGROUND

• 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.

  PMID: 27651882 BACKGROUND

• 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.

  PMID: 29777632 BACKGROUND

• 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.

  PMID: 27717210 BACKGROUND

• 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.

  PMID: 19563288 BACKGROUND

• 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.

  PMID: 29240201 BACKGROUND

• 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.

  PMID: 10711621 BACKGROUND

• 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.

  PMID: 30892767 BACKGROUND

• 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.

  PMID: 23050490 BACKGROUND

• 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.

  PMID: 17309597 BACKGROUND

Study Officials

• Noor Alhuda Ewaz Ali, DDS

  MSc student in Periodontics, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Suleiman Dayoub, DDS MSc PhD

  Professor of Periodontics, University of Damascus Dental School

  STUDY CHAIR

• Mohammad Alharissy, DDS MSc PhD

  Assistant Professor of Periodontics, Academic Staff Member At Wadi International University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: split-mouth design.

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 9, 2019
• Study Start: August 25, 2019
• Primary Completion: June 30, 2020
• Study Completion: August 1, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)