Treatment of Multiple Gingival Recession Defects Using a New Xenogenic Collagen Membrane Compared to Connective Tissue Graft: a Randomized Controlled Split-mouth Clinical Study

Study Overview
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Brief Summary
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Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft. We want to show if mucogain matrix used in tunnel technique to recover RTI Cairo recessions defects could be an alternative to connective tissue graft

Official Title
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Mucogain Matrix Versus Connective Tissue Graft: MUCOGREFFE Project

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Treatment of gingival recessions


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient with 3 contiguous, symmetrical and bilateral RTI Cairo gingival recessions (Miller Class 1) (i.e. 6 recessions) Patient non-smoker Patient affiliated to social security Patient signed informed consent. Exclusion criteria: Patient with or having presented an acute or chronic severe cardiovascular, kidney, liver, gastrointestinal, allergic, endocrine, neuropsychiatric pathology, developed cancer of the upper aero digestive tract treated with radiotherapy Patient with severe hemorrhinopathy Patient treated with oral retinoids, bisphosphonates, oral or anticonvulsants Patient who has taken steroidal or non-steroidal anti-inflammatory therapy, anti-cancer or immunosuppressive chemotherapy within the last 6 months. Patient with contraindication to necessary and pre-, per- or post-operative treatments Follow-up of the patient seemed difficult by the investigator Patient with insufficient oral hygiene incompatible with oral surgery

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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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
Interventional Model Description: Case-control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - Mucogain matrix on right<br>The patient will receive mucogain matrix on right side and connective tissue graft on left side. | Procedure: Treatment of gingival recessions<br>* Patients will have a surgery for their gingival recessions. They will be enrolled in the split mouth-study. They will have on one side mucogain matrix transplant, an on another side they will have the gold standard procedure<br>|
| Experimental: B - Mucogain matrix on left<br>The patient will receive mucogain matrix on left side and connective tissue graft on right side. | Procedure: Treatment of gingival recessions<br>* Patients will have a surgery for their gingival recessions. They will be enrolled in the split mouth-study. They will have on one side mucogain matrix transplant, an on another side they will have the gold standard procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean root coverage obtained with both techniques | To compare the mean root coverage obtained with the Creos® Mucogain matrix and connective tissue graft in the treatment of Cairo RT1 class maxillary recessions (Miller Class 1). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain with both techniques | To compare postoperative pain with both techniques | 6 months | 
| Postoperative complications with both techniques | To compare the occurrence of postoperative complications (haemorrhage, edema) within the first 10 days. | 10 days |