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

Study Overview
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Brief Summary
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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.

Official Title
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Xenogenous Collagen Matrix Graft Associated or Not With Enamel Matrix Derivative Proteins in the Treatment of Gingival Recession Class I and II of Miller: Randomized Controlled Clinical Study

Conditions
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Gingival Recession

Intervention / Treatment
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* Device: Mucograft
* Device: Emdogain
* Procedure: Coronally Advanced flap


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 ≥ 2.5 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: CAF+MC+EMD<br>Coronally Advanced Flap with Mucograft and Emdogain | Device: Mucograft<br>* Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.<br>Device: Emdogain<br>* Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.<br>Procedure: Coronally Advanced flap<br>* Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.<br>|
| Active Comparator: CAF+MC<br>Coronally Advanced Flap with Mucograft | Device: Mucograft<br>* Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.<br>Procedure: Coronally Advanced flap<br>* Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.<br>|
| Active Comparator: CAF+EMD<br>Coronally Advanced Flap with Emdogain | Device: Emdogain<br>* Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.<br>Procedure: Coronally Advanced flap<br>* Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.<br>|
| Active Comparator: CAF<br>Coronally Advanced Flap alone | Procedure: Coronally Advanced flap<br>* Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.<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, Coronally advanced flap, Periodontal regeneration