NCT02656732

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 20 Years – 54 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gingival Recession

Interventions

Type	Name	Description
BIOLOGICAL	amnion chorion allograft membrane	Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject.
PROCEDURE	coronally advanced flap with the subepithelial connective tissue graft	coronally advanced flap with the placement of subepithelial connective tissue graft harvested from the palate

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-04-01
• Completion: 2015-10-01
• First posted: 2016-01-15
• Last updated: 2017-04-24