Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage

Phase 4

Completed

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

• Registration Number: NCT02456337
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

The purpose of this study is to evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-05-25
• Study First Submitted QC: 2015-05-25
• Study First Posted: 2015-05-28
• Status Verified: 2015-12
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Age ≥ 18 years.
• Presence of at least one Class I or II Miller gingival recession ≥ 2.5 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
CAF+MC	Coronally Advanced flap	Coronally Advanced Flap with Mucograft
CAF+MC+EMD	Emdogain	Coronally Advanced Flap with Mucograft and Emdogain
CAF+MC	Mucograft	Coronally Advanced Flap with Mucograft
CAF+MC+EMD	Mucograft	Coronally Advanced Flap with Mucograft and Emdogain
CAF	Coronally Advanced flap	Coronally Advanced Flap alone
CAF+EMD	Emdogain	Coronally Advanced Flap with Emdogain
CAF+MC+EMD	Coronally Advanced flap	Coronally Advanced Flap with Mucograft and Emdogain
CAF+EMD	Coronally Advanced flap	Coronally Advanced Flap with Emdogain

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