Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions

Study Overview
=================
Brief Summary
-----------------
The goal of the present study is to compare the amount of root coverage resulting from subepithelial connective tissue graft and acellular dermal matrix associated with tunnel technique among patients suffering from multiple gingival recession.

Detailed Description
-----------------
Acellular dermal matrix with Tunnel technique will offers great advantages for patients with multiple gingival recession as regards decrease surgical time, Post-Operative pain and root coverage, clinical attachment level, width of Keratinized gingiva, gingival biotype compared to subepithelial connective tissue graft with Tunnel technique.

Official Title
-----------------
Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions (Randomized Clinical Trial, Parallel Design)

Conditions
-----------------
Gingival Recession

Intervention / Treatment
-----------------
* Biological: Acellular Dermal Matrix
* Procedure: Tunnel technique with the subepithelial connective tissue graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with facial multiple gingival recession defects classified as either class I or II defects according to Miller's classification (Miller 1985). Subjects aged between 18 - 60 years old. Patients should be free from any systemic disease that may affect normal healing of tissue, and predictable outcome. Patients with good oral hygiene. Exclusion Criteria: Current and former smokers. Pregnant females. Subjects received any periodontal therapy for minimum of 6 months prior to the study. Subjects taking drugs known to interfere with wound healing. Subjects with unacceptable oral hygiene with plaque index >2. Teeth with non-carious cervical lesions (NCCL), cervical caries and malalignment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tunnel technique with acellular dermal matrix<br>the tunnel technique involves separation of the gingiva, then acellular dermal matrix interposed between the flap and the root surface. | Biological: Acellular Dermal Matrix<br>* Puros Dermis is a collagenous membrane derived from solvent preserved,human dermis, works as biological scaffold for the new formation of vasculated connective tissue.<br>* Other names: Puros Dermis Allograft Tissue Matrix;Procedure: Tunnel technique with the subepithelial connective tissue graft<br>* Tunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate<br>* Other names: autogenous connective tissue graft;|
| Active Comparator: subepithelial connective tissue graft<br>Tunnel is prepared and sub-epithelial connective tissue graft is harvested from the palate and placed under the flap. | Biological: Acellular Dermal Matrix<br>* Puros Dermis is a collagenous membrane derived from solvent preserved,human dermis, works as biological scaffold for the new formation of vasculated connective tissue.<br>* Other names: Puros Dermis Allograft Tissue Matrix;Procedure: Tunnel technique with the subepithelial connective tissue graft<br>* Tunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate<br>* Other names: autogenous connective tissue graft;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient Satisfaction . | measured by VAS scale | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| root coverage | measured by periodontal probe | 1 year | 
| Clinical Attachment Level | measured by periodontal probe | 1 year | 
| Width of Keratinized Tissue | measured by periodontal probe | 1 year | 
| Gingival Bio-type | measured by endodontics file | 1 year |