Phase IV Study of Coronally Advanced Flap With or Without Porcine Collagen Matrix for Treatment of Gingival Recession: a Randomized Controlled Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Gingival Recession
- Sponsor
- Enilson Antonio Sallum
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Recession Reduction
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Enilson Antonio Sallum
Chair of the Department of Prosthodontics and Periodontics, Division of Periodontics, Piracicaba Dental School
University of Campinas, Brazil
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
Recession Reduction
Time Frame: 6 months
Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.
Secondary Outcomes
- Complete root coverage(6 months)