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

Cairo University (CU)

Status: Completed

Conditions: Gingival Recession

Treatments: Procedure: coronally advanced flap with the subepithelial connective tissue graft; Biological: amnion chorion allograft membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT02656732

AC_SCTG

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 54 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

coronally advanced flap with amnion chorion membrane

Experimental group

Description:

coronally advanced flap was reflected and amnion chorion allograft membrane was placed under the flap as a guided tissue regeneration barrier.

Treatment:

Biological: amnion chorion allograft membrane

subepithelial connective tissue graft

Active Comparator group

Description:

coronally advanced flap was reflected and subepithelial connective tissue graft was harvested from the palate and placed under the flap.

Treatment:

Procedure: coronally advanced flap with the subepithelial connective tissue graft