Coronally Advanced Flap With or Without Porcine Collagen Matrix for Root Coverage

Phase 4

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Coronally Advanced Flap; Device: Mucograft

• Registration Number: NCT02242500
• Lead Sponsor: Enilson Antonio Sallum

Brief Summary

The purpose of this study is to compare the clinical outcomes after coronally advanced flap technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of single gingival recessions. For this blinded randomized controlled clinical trial, 40 patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters evaluated will be probing depth, clinical attachment level, gingival recession height, height and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45 days, 2, 3 and 6 months after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2014-09-13
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-17
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-26
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age ≥ 18 years.
• Presence of at least one Class I or II Miller gingival recession ≥ 2 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (< 0.5 mm): A + (Pini-Prato et al. 2010).
• Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
• Full-mouth visible plaque index ≤ 20% (Ainamo & Bay 1975).
• Full-mouth sulcus bleeding index ≤ 20% (Mühlemann & Son 1971).

Exclusion Criteria

• Smoking.
• Pregnancy.
• Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
• Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
• Previous periodontal surgery in the area.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coronally advanced flap	Coronally Advanced Flap	Coronally advanced flap procedure alone
Coronally advanced flap + Mucograft	Coronally Advanced Flap	coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft
Coronally advanced flap + Mucograft	Mucograft	coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft

Primary Outcome Measures

Name	Time	Method
Recession Reduction	6 months	Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.

Secondary Outcome Measures

Name	Time	Method
Complete root coverage	6 months	Assessed as percentage of sites with complete root coverage

Trial Locations

Locations (1)

Piracicaba Dental School, State University of Campinas; 🇧🇷 Piracicaba, São Paulo, Brazil