Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage
- Conditions
- Gingival Recession
- Interventions
- Biological: amnion chorion allograft membraneProcedure: coronally advanced flap with the subepithelial connective tissue graft
- Registration Number
- NCT02656732
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description coronally advanced flap with amnion chorion membrane amnion chorion allograft membrane coronally advanced flap was reflected and amnion chorion allograft membrane was placed under the flap as a guided tissue regeneration barrier. subepithelial connective tissue graft coronally advanced flap with the subepithelial connective tissue graft coronally advanced flap was reflected and subepithelial connective tissue graft was harvested from the palate and placed under the flap.
- Primary Outcome Measures
Name Time Method recession depth Change in mm from baseline before surgical procedure to follow up at 6 months. It is measured as the distance from the cemento-enamel junction to the gingival margin representing the amount of root coverage.
- Secondary Outcome Measures
Name Time Method Recession Width Change in mm from baseline before surgical procedure to follow up at 6 months. It is measured as the distance from mesial and distal papillae along cemento-enamel junction.
Width of keratinized gingiva Change in mm from baseline before surgical procedure to follow up at 6 months. It is measured from the mucogingival junction to the free gingival margin.
Patient reported outcomes taken after completion of the study at 6 months 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.
Clinical attachment level Change in mm from baseline before surgical procedure to follow up at 6 months. It is measuring the distance from the apical end of periodontal probe to cemento-enamel junction.
Probing pocket depth Change in mm from baseline before surgical procedure to follow up at 6 months. It is measuring the distance from the base of pocket to the gingival margin.
Tissue Biotype Change in mm from baseline before surgical procedure to follow up at 6 months. 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
root coverage esthetic score score taken after completion of the study at 6 months The clinical esthetic evaluation was performed without magnification to evaluate gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment and gingival color