Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage

Study Overview
=================
Brief Summary
-----------------
The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20 to 54 years) suffering from Miller's class I or II gingival recession. Patients were randomly assigned into two equal groups; control group; the coronally advanced flap with the subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap with amnion chorion allograft membrane (CAF+AC).

Detailed Description
-----------------
The participants were randomly assigned to receive coronally advanced flap (CAF) with amnion chorion membrane or CAF with subepithelial connective tissue graft using a simple randomization procedure with a 1:1 allocation ratio. A computer generated randomization list was drawn up by a faculty member who was not involved in the recruitment. Allocation concealment was achieved by sealed coded opaque envelopes that contained the treatment to be performed to the enrolled subjects based on the randomized numbers. Consequently, patients were allocated to either AC membrane (intervention) or SCTG (control) groups. The sealed envelope containing treatment assignment was opened at time of the surgery and the number was picked by another person other than the operator.

Official Title
-----------------
Clinical Evaluation of Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage: A Randomized Controlled Clinical Trial.

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

Intervention / Treatment
-----------------
* Biological: amnion chorion allograft membrane
* Procedure: coronally advanced flap with the subepithelial connective tissue graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged between 18 - 60 years old. Subjects with facial gingival recession defects in anterior and premolar teeth classified as either class I or II defects according to Miller's classification. Subjects able to tolerate surgical periodontal procedures. Accepts the 6 months follow-up period. Exclusion Criteria: Current and former smokers. Pregnant females. Subjects received any periodontal therapy for a 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, cervical caries and malalignment.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 54 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: coronally advanced flap with amnion chorion membrane<br>coronally advanced flap was reflected and amnion chorion allograft membrane was placed under the flap as a guided tissue regeneration barrier. | Biological: amnion chorion allograft membrane<br>* Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject.<br>* Other names: BioXclude™,Snoasis Medical products, USA.;|
| Active Comparator: subepithelial connective tissue graft<br>coronally advanced flap was reflected and subepithelial connective tissue graft was harvested from the palate and placed under the flap. | Procedure: coronally advanced flap with the subepithelial connective tissue graft<br>* coronally advanced flap 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 |
| --- | --- | --- |
| recession depth | It is measured as the distance from the cemento-enamel junction to the gingival margin representing the amount of root coverage. | Change in mm from baseline before surgical procedure to follow up at 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession Width | It is measured as the distance from mesial and distal papillae along cemento-enamel junction. | Change in mm from baseline before surgical procedure to follow up at 6 months. | 
| Width of keratinized gingiva | It is measured from the mucogingival junction to the free gingival margin. | Change in mm from baseline before surgical procedure to follow up at 6 months. | 
| Probing pocket depth | It is measuring the distance from the base of pocket to the gingival margin. | Change in mm from baseline before surgical procedure to follow up at 6 months. | 
| Clinical attachment level | It is measuring the distance from the apical end of periodontal probe to cemento-enamel junction. | Change in mm from baseline before surgical procedure to follow up at 6 months. | 
| Tissue Biotype | It is measured by penetrating the gingiva with the periodontal probe down to bone after giving local anesthesia to measure the thickness of gingival tissues | Change in mm from baseline before surgical procedure to follow up at 6 months. | 
| root coverage esthetic score | The clinical esthetic evaluation was performed without magnification to evaluate gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment and gingival color | score taken after completion of the study at 6 months | 
| Patient reported outcomes | Patients were given certain questions regarding not regretting to perform the surgery, root hypersensitivity and aesthetic satisfaction to be answered at the 6 month follow-up for assessing their satisfaction with the whole procedure. | taken after completion of the study at 6 months |