The Use of Mucograft® to Treat Gingival Recession

Study Overview
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Brief Summary
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Twenty patients with gingival recession will be enrolled in this trial. Gingival recession will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while on the opposite side a connective tissue graft (from the palate) will be applied with a CAF. Patients will be followed for 3 and 6 months by measuring the clinical indexes and statistical analyses will be performed to compare the results and to assess the success of Mucograft®.

Detailed Description
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Many surgical techniques have used to treat gingival recession such aas repositioned flaps, autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft® (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue regeneration and considered the ideal solution to autogenous soft tissue grafts and it provides an ideal matrix for blood vessel and soft tissue ingrowth.

Official Title
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Clinical Applications of 3D Collagen Matrix (Mucograft®) in the Management of Gingival Recession: a Randomized Controlled Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Mucograft
* Procedure: Connective Tissue Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of Type I or II (Miller Classification) of gingival recession Exclusion Criteria: Smoking Pregnancy or lactating Presence of any systematic diseases can affect the periodontal surgery. Subjects with significant moderate to severe periodontal disease. Patients under orthodontic treatment Presence of restorative materials (e.g. crown) Effectiveness of frenum Subjects have failed to maintain good plaque control. Subjects having previous surgical treatment for covering the recession in the chosen area.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mucograft<br>One side of the mouth will be subjected to Mucograft in this split-mouth study design. | Procedure: Mucograft<br>* This method of grafting will be used to treat the gingival recession using coronally advanced flaps.<br>|
| Active Comparator: Connective tissue graft<br>The opposite side of the mouth will be subjected to a connective tissue graft. | Procedure: Connective Tissue Graft<br>* This will be used in the traditional manner to correct gingival recession<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Clinical Attachment Level Index | Clinical Attachment Level is dependent on measuring the pocket depth as well as the amount of gingival recession using specific tools. The measurement is going to be recorded in millimeters. | Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Probing Depth | Probing depth is going to be measuring using a specific tool (UNC-15 probe). | Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively | 
| Change in Gingival Recession | Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues. | Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively | 
| Change in Gingival Biotype | Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin). | Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively | 
| Change in Root Coverage Index | The amount of root exposure will be measured and compared to the total length of the root | Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively | 
| Change in Resistance to Muscular Pull | The cheeks or lips are going to be retracted by hand or by a mirror in order to see the movement of the free gingival tissues. The movement will be esitmated in millimeters. | Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively | 
| Change in Color Match Index |  | Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively | 
| Shrinkage index at three months |  | Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively. | 
| Shrinkage index at six months |  | Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gingival graft, free gingival graft, coronally advanced flap, reduced keratinized gingiva