Comparison Between Connective Graft and Xenogeneic Matrix, in Patients With Multiple Gingival Recessions

Study Overview
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Brief Summary
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Subepithelial connective tissue graft (SCTG) is considered the gold standard for root coverage treatment. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of MC are very promising, both for root coverage as well as for the gain of keratinized tissue. The present study consists of a parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (upper central incisors, Lateral and canine).

Detailed Description
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Obtaining an aesthetic smile is one of the main reasons for the patient's demand for dental treatment, especially when it comes to gingival recession. However, there is a lack of evidence in the literature explaining the most appropriate type of treatment for multiple recessions in aesthetic areas. For unitary gingival recessions, the subepithelial connective tissue graft (SCTG) is considered the gold standard because it presents greater predictability for root coverage. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of CM are very promising, both for root coverage as well as for the gain of keratinized mucosa. The present study will consist of a double-blind parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (central incisors, Lateral, upper canine). All measurements will be evaluated initially and in the periods of 3, 6, and 12 months after the surgical procedure.

Official Title
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Xenogeneic Collagen Matrix and Connective Tissue Graft Comparison for Multiple Gingival Recessions in Esthetic Areas: A Non-inferiority Clinical Trial

Conditions
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Gingival Recession, Generalized

Intervention / Treatment
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* Procedure: Root coverage surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of multiple gingival recessions ≥ 2 mm, only in aesthetic areas (upper central and lateral incisive, and canine); Miller class I and II gingival recession areas Non-abrasive, erosive, or carious root surfaces Unrotated, non-extruded, and non-movable teeth Systemically healthy patients without contraindication to periodontal surgical procedures Exclusion Criteria: Smokers Pregnant women and infants Patients with a history of periodontal disease or recurrent abscess formation Patients previously submitted to surgical procedures for root coverage Patients taking anti-convulsant drugs Antihypertensives, contraceptives or immunosuppressors Patients with low oral hygiene (plaque and bleeding index over 20%)

Ages Eligible for Study
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Minimum Age: 15 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control SCTG<br>Root coverage surgery with subepithelial connective tissue graft to an extensive treat multiple gingival recessions in aesthetic areas | Procedure: Root coverage surgery<br>* Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM<br>|
| Experimental: Test CM<br>Root coverage surgery with Mucograft® collagen matrix to treat an extensive multiple gingival recessions in aesthetic areas | Procedure: Root coverage surgery<br>* Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival recession depth (GRD) | Distance in millimeters from ECJ to gingival margin at three points (mesial, center and distal); Distance from cemento-enamel junction to gingival margin = 0 mm | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratinized mucosa width | Keratinized mucosa width measured with a periodontal probe in millimeters Ideal if keratinized mucosa width > 5mm | year | 
| Dentin hypersensitivity | Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale Ideal if scale = 0 | year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingival Recession, Collagen Matrix, Periodontics