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

Study Overview
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Brief Summary
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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.

Official Title
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Phase IV Study of Coronally Advanced Flap With or Without Porcine Collagen Matrix for Treatment of Gingival Recession: a Randomized Controlled Clinical Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Coronally Advanced Flap
* Device: Mucograft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coronally advanced flap + Mucograft<br>coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft | Procedure: Coronally Advanced Flap<br> <br> Device: Mucograft<br> <br> * Other names: Porcine collagen matrix for soft tissue regeneration;|
| Other: Coronally advanced flap<br>Coronally advanced flap procedure alone | Procedure: Coronally Advanced Flap<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession Reduction | Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete root coverage | Assessed as percentage of sites with complete root coverage | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingival recession/surgery, Collagen/therapeutic use, Root coverage, Treatment outcome