Coronally Advanced Flap in Combination With Acellular Dermal Matrix and Enamel Matrix Derivatives for Root Coverage

Study Overview
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Brief Summary
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The aim of this study is to compare the clinical outcomes of root coverage procedures, using coronally advanced flap in combination with acellular dermal matrix with or without enamel matrix derivatives .

Detailed Description
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coverage of gingival recession defects has been considered as a matter of interest for dental practitioners.subjects with a paired gingival recession defect will be selected from the patients who sought dental treatment at our department.Random allocation of the treatment sites to test (CAF+ EMD+ADM) and control (CAF + ADM) groups will be performed by a person who is external to the study and using a computerized selection of random numbers for allocation of the study groups.The parameters of the study are as following items: probing depth( PD), clinical attachment level (CAL), width of keratinized tissue (WKT), recession depth from cemento- enamel junction (RD), recession width (RW), distance between mucogingival junction and the stent (MGJ), Plaque (PI) and gingival (GI) indices and root coverage percentage (RC) and the patients will be followed up for 6 months.

Official Title
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Coronally Advanced Flap in Combination With Acellular Dermal Matrix With or Without Enamel Matrix Derivatives for Root Coverage

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: CAF+ADM+EMD
* Procedure: CAF+ADM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having no systemic disease affecting the periodontium, No contraindication for elective surgery, Adequate oral hygiene , No previous surgical attempts for root coverage at the studying sites, Vital teeth and signing a witness letter. Exclusion Criteria: Smoking, presence of a restorations on tooth surface for test and control teeth, Pregnancy, Being under treatment with steroids, Peri-apical infection, Indication for antibiotic prophylaxis prior to dental treatments

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (CAF+ADM+EMD)<br>using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD). | Procedure: CAF+ADM+EMD<br>* using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).<br>* Other names: Emdogain®;|
| Active Comparator: (CAF + ADM)<br>root coverage procedure by using a coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) | Procedure: CAF+ADM<br>* using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) without enamel matrix derivatives (EMD) for root coverage procedures.<br>* Other names: Emdogain®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of root coverage |  | at baseline, 2 and 6 months after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures |  | 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronally advanced flap, gingival recession, enamel matrix protein, acellular dermal matrix, root coverage