Treatment of Multiple Gingival Recessions

Study Overview
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Brief Summary
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Gingival recession (GR) is frequently associated with deterioration in dental esthetics and dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced flaps (CAF) appears to be more predictable, and may be considered the gold standard procedure. However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs because of the need for a donor surgical area, which may increase the risk of surgical complications like bleeding, as well as increases post-operative discomfort and the period of the surgical procedure. Another biomaterial, a new collagen matrix (CM) has been used as a substitute for the SCTG. The use of CM was associated with a significant reduction in post-operative morbidity, less post-operative pain and discomfort in the patient, and more esthetic satisfaction.

Official Title
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Treatment of Multiple Gingival Recessions With Collagen Matrix Versus Subepithelial Connective Tissue Graft: A Non-inferiority Randomized Clinical Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Coronally advanced flap (CAF)
* Drug: Collagen Matrix
* Procedure: Subepithelial connective tissue graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients will be included in the study if they fulfill the following inclusion criteria: a clinical diagnosis of multiple-recession type defects at maxillary canines and premolars with at least one GR ≥ 3mm in depth; areas of Miller's Class I or II GR; teeth without root abrasions or caries. Exclusion Criteria: - The exclusion criteria used will be as follows: patients allergic to collagen a history of smoking (within the previous 6 months) pregnancy or lactation a history of destructive periodontal disease or the formation of recurrent abscesses root caries at the site of recession previous surgical root coverage procedures systemic healing disorders (for example, acquired immunodeficiency syndrome [AIDS], diabetes mellitus or risk factors evaluated by a medical doctor) periodontal disease, or poor plaque control (full mouth plaque index > 20%). The exclusion criteria for teeth will be: noncarious cervical lesions (erosion, abfraction etc.) any type of previous cervical restoration extrusion giroversion mobility a prominent root surface.

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen Matrix plus coronally advanced flap (CAF)<br>A new collagen matrix (Mucograft) associated to coronally advanced flap | Procedure: Coronally advanced flap (CAF)<br>* The test group will be treated by means of the association of Collagen Matrix + Coronally Advanced Flap. As treatment, the control group will receive the association of a subepithelial Conjunctive Tissue Graft + Coronally Advanced Flap. The aim of both procedures will be to obtain root coverage. All these procedures will be performed in a standardized manner.<br>* Other names: Coronally advanced flaps associated with collagen matrix;Drug: Collagen Matrix<br>* A new collagen membrane<br>* Other names: Mucograft;|
| Active Comparator: Subepithelial connective tissue graft plus CAF<br>Subepithelial connective tissue graft associated to coronally advanced flap | Procedure: Coronally advanced flap (CAF)<br>* The test group will be treated by means of the association of Collagen Matrix + Coronally Advanced Flap. As treatment, the control group will receive the association of a subepithelial Conjunctive Tissue Graft + Coronally Advanced Flap. The aim of both procedures will be to obtain root coverage. All these procedures will be performed in a standardized manner.<br>* Other names: Coronally advanced flaps associated with collagen matrix;Procedure: Subepithelial connective tissue graft<br>* Connective tissue graft<br>* Other names: connective tissue graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of root coverage (RC) | The primary clinical outcome will be percentage of root coverage (RC) at 12 months | 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reductions in recession depth (RRD) | Measured from the cementum-enamel junction (CEJ) up to the highest point of the gingival margin | At the baseline, 3-month, 6-month and 12-months | 
| Complete root coverage of the gingival recessions (CRC) |  | At the baseline, 3-month, 6-month and 12-months | 
| Recession width (RW) at the cemento-enamel junction |  | At the baseline, 3-month, 6-month and 12-months | 
| Relative clinical attachment level (RCAL) | Measured from a fixed point (stent) prepared on the acrylic guide up to the base of the gingival sulcus. | At the baseline, 3-month, 6-month and 12-months | 
| Probing depth (PD) | Calculated as RCAL- PD; | At the baseline, 3-month, 6-month and 12-months | 
| keratinized tissue width (KT) | From the free gingival margin to the mucogingival junction. | At the baseline, 3-month, 6-month and 12-months | 
| Gain in thickness of gingival tissue (GT) | With an injection needle and a silicon marker, 2mm below the gingival margin. | At the baseline, 3-month, 6-month 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, Plastic surgery, Connective tissue graft, Mucograft