Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions

Not Applicable

• Conditions: Gingival Recession
• Interventions: Procedure: Root coverage with collagen matrix graft; Procedure: Root coverage with subepithelial connective tissue graft; Other: Basic periodontal treatment

• Registration Number: NCT03675334
• Lead Sponsor: University of Sao Paulo

Brief Summary

Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. The CM has the advantage of no need of a second surgical area and availability overcoming the limitations of donor site in autograft.

The aim of this study is to investigate the use of Mucoderm® in root coverage procedures combined with extended coronally positioned flap (ECAF), test group (TG), in comparison to the connective tissue graft associated with the ECAF, control group (CG).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Status Verified: 2018-09
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-14
• Last Update Submitted: 2018-09-14
• Study First Posted: 2018-09-18
• Last Update Posted: 2018-09-18
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• CEJ without significant damage;
• localized bilateral RT1 gingival recession ≥3 mm in the same arch

Exclusion Criteria

• previous periodontal surgical treatment on the involved sites;
• smokers
• pregnants or lactating
• compromised systemic health and contraindications for periodontal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Basic periodontal treatment	the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft.
Test Group	Root coverage with collagen matrix graft	Active comparator: gingival recession the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions
Test Group	Basic periodontal treatment	Active comparator: gingival recession the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions
Control Group	Root coverage with subepithelial connective tissue graft	the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft.

Primary Outcome Measures

Name	Time	Method
Root coverage after 6 months	6 months	Root coverage is measured by the difference between the gingival recession height at 6 months and baseline

Secondary Outcome Measures

Name	Time	Method
Keratinized tissue gain after 6 months	6months	The difference between keratinized tissue width and depth at 6 months and at baseline

Trial Locations

Locations (1)

School of Dentistry of Ribeirao Preto - University of Sao Paulo; 🇧🇷 Ribeirão Preto, Sao Paulo, Brazil