Evaluating Coronally Advanced Flap With Platelet-rich Fibrin Membrane and Chorion Membrane for Gingival Recession
NCT07308405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-12-29
Summary
The present study was a double-blind, randomised, controlled clinical trial with a parallel design, comparing the coronally advanced flap (CAF) with platelet-rich fibrin (PRF) and chorion membrane (CM) for the treatment of isolated gingival recession defects. A total of 50 patients were randomly divided into; Experimental site A: Twenty five sites were treated with coronally advanced flap (CAF) and platelet-rich fibrin (PRF) membrane; Experimental site B: Twenty five sites were treated with coronally advanced flap (CAF) and chorion membrane (CM)The study was conducted in accordance with the Declaration of Helsinki, protocol was developed and ethical clearance was obtained from the Institutional Ethics Committee, Institute of Dental Sciences, Bareilly, India \[IDS/ETHCC/14/08\]. As per protocol, a study was conducted in five phases: (1) initial screening; (2) initial therapy and clinical measurements; (3) surgical therapy; (4) maintenance phase; and (5) post-operative evaluation after 1 month, 3 months, and 6 months.
Conditions
- Gingival Recession
Interventions
- PROCEDURE
-
Coronally advanced flap (CAF) with platelet-rich fibrin (PRF)
Description: After achieving adequate anaesthesia with 2% lignocaine (1:80,000 adrenaline), an intrasulcular incision was made on the buccal aspect of the involved teeth. Two horizontal incisions were placed from the mesial and distal angles to the papillae at the CEJ, without involving adjacent gingival margins. From their ends, two bevelled, slightly divergent oblique incisions were extended beyond the mucogingival junction, creating a trapezoidal flap. A full-thickness flap was raised up to the MGJ, followed by split-thickness dissection apically, with periosteal release to allow passive coronal mobilization. Adequate mobilization was defined as the flap margin reaching passively coronal to the CEJ. The coronal papilla soft tissue was de-epithelialized to prepare connective tissue beds for suturing of the coronally advanced flap. At the recipient site, the prepared PRF membrane was placed over the denuded root surfaces.
- PROCEDURE
-
A similar surgical procedure was followed for the recipient bed preparation similar to that for the PRF membrane. A chorion membrane (Tissue bank, Tata Memorial Hospital, Mumbai, Maharashtra, India) o
Sponsors & Collaborators
-
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
lead OTHER
Principal Investigators
-
Shatyajit Naik, MDS · Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-12-04
- Primary Completion
- 2016-05-31
- Completion
- 2016-10-31
Countries
- India
Study Locations
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