Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions

Study Overview
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Brief Summary
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Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. The CM has the advantage of no need of a second surgical area and availability overcoming the limitations of donor site in autograft. The aim of this study is to investigate the use of Mucoderm® in root coverage procedures combined with extended coronally positioned flap (ECAF), test group (TG), in comparison to the connective tissue graft associated with the ECAF, control group (CG).

Official Title
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Clinical Comparison Between the Use of a Connective Tissue Graft or a Porcine Collagen Matrix (Mucoderm) for Treatment of Gingival Recessions Type 1: a Randomized Controlled Clinical Study.

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Root coverage with collagen matrix graft
* Procedure: Root coverage with subepithelial connective tissue graft
* Other: Basic periodontal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CEJ without significant damage; localized bilateral RT1 gingival recession ≥3 mm in the same arch Exclusion Criteria: previous periodontal surgical treatment on the involved sites; smokers pregnants or lactating compromised systemic health and contraindications for periodontal surgery

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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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
Interventional Model Description: Randomized Controlled Split-mouth clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Group<br>Active comparator: gingival recession the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions | Procedure: Root coverage with collagen matrix graft<br>* at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.<br>Other: Basic periodontal treatment<br>* profilaxis, coronary polishing and scaling and root planning<br>|
| Placebo Comparator: Control Group<br>the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft. | Procedure: Root coverage with subepithelial connective tissue graft<br>* at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.<br>Other: Basic periodontal treatment<br>* profilaxis, coronary polishing and scaling and root planning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root coverage after 6 months | Root coverage is measured by the difference between the gingival recession height at 6 months and baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratinized tissue gain after 6 months | The difference between keratinized tissue width and depth at 6 months and at baseline | 6months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trial, root coverage, biomaterials, collagen matrix, coronally advanced flap