Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix

Study Overview
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Brief Summary
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Gingival recessions are often successfully treated by coronally advanced flap technique (CAF) associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for root coverage. CAF technique was not developed for use with CM and has shown limited results when applied to the CM. The aim of this study was to compare and show the benefits of the extended flap technique (EFT) compared to CAF technique using CM for root coverage.

Official Title
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Comparison of Two Surgical Techniques to Optimize the Treatment of Gingival Recessions Using a Gingival Graft Substitute.

Conditions
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Gingival Recession

Intervention / Treatment
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* Device: root coverage comparing two techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 25 to 50 years old bilateral gingival recession type Miller class I or II with 3 mm in height and less than 3mm of keratinized tissue non-molar teeth Exclusion Criteria: diabetics pregnant women chronic use of medication periodontitis

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: coronal advanced technique<br>root coverage with the porcine collagen matrix using the coronal advanced technique (standard technique) | Device: root coverage comparing two techniques<br>* The aim of this study was to compare and show the benefits of the extended flap technique (new technique) compared to coronal advanced technique (gold standard technique) both techniques using the porcine collagen matrix for root coverage.<br>* Other names: coronal advanced flap technique;|
| Experimental: extended flap technique<br>root coverage with the porcine collagen matrix using the extended flap technique (new surgical technique) | Device: root coverage comparing two techniques<br>* The aim of this study was to compare and show the benefits of the extended flap technique (new technique) compared to coronal advanced technique (gold standard technique) both techniques using the porcine collagen matrix for root coverage.<br>* Other names: coronal advanced flap technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing changes for Root coverage measure (in millimeter) from baseline at 3, 6 and 12 months | At the mid-buccal point of the involved tooth, the gingival recession height was measure by the same operator, who was previously calibrated (intra-examiner calibration) using a digital paquimeter. | Change from Baseline at 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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root coverage, gingival recession, periodontal surgery