Evaluating Coronally Advanced Flap With Platelet-rich Fibrin Membrane and Chorion Membrane for Gingival Recession

NCT07308405 | Completed DMC

• 1 other identifier: IDS/ETHCC/14/08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Coronally advanced flap; platelet rich fibrin; root coverage; chorion membrane; Gingival Recession Localized Moderate

Outcome Measures

Primary Outcomes (5)

• Recession depth (RD)

  Measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin

  Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits

• Recession width (RW)

  Measured between mesial and distal papillae across the buccal surface at the CEJ level

  Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits

• Clinical attachment level (CAL)

  Measured from the CEJ to the bottom of the gingival sulcus;

  Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits:

• Width of keratinized gingiva (WKG)

  Measured from the gingival margin to the mucogingival junction (MGJ)

  Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits

• Assessment of gingival biotype

  Evaluated based on the transparency of the probe through the gingival margin while probing the sulcus at the midfacial aspect of teeth

  Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits

Study Arms (2)

Experimental site A: patient were treated with coronally advanced flap and PRF

EXPERIMENTAL

Twenty five sites in each of 25 patient were treated with coronally advanced flap (CAF) and platelet-rich fibrin (PRF) membrane;

Procedure: Coronally advanced flap (CAF) with platelet-rich fibrin (PRF)

Experimental site B: patient were treated with coronally advanced flap (CAF) and CM

EXPERIMENTAL

Twenty five sites in each of other 25 patient were treated with coronally advanced flap (CAF) and chorion membrane (CM)

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

Interventions

Coronally advanced flap (CAF) with platelet-rich fibrin (PRF) PROCEDURE

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.

Experimental site A: patient were treated with coronally advanced flap and PRF

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 PROCEDURE

Experimental site B: patient were treated with coronally advanced flap (CAF) and CM

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-35 years
• In good general health
• Isolated Miller's Class I or II gingival recession ≥ 2 mm
• ≥ 1 mm keratinised tissue apical to root exposure
• Identifiable CEJ (cementoenamel junction)

You may not qualify if:

• Poor oral hygiene after Phase I therapy
• Smoking or alcohol use
• Occlusal disharmony
• Parafunctional habits
• Non-vital or endodontically treated teeth
• Caries, restorations, or crowns at the CEJ
• Frenum pull at the attached gingiva
• Previous surgery in the area

Sponsors & Collaborators

• Institute of Dental Sciences, Bareilly, Uttar Pradesh, India: lead

Study Sites (1)

Department of Periodontics and implantology , Institute of Dental sciences, Bareilly, Uttar Pradesh, India

Bareilly, Uttar Pradesh, India

Location

Related Publications (3)

• Bertl K, Spineli LM, Mohandis K, Stavropoulos A. Root coverage stability: A systematic overview of controlled clinical trials with at least 5 years of follow-up. Clin Exp Dent Res. 2021 Oct;7(5):692-710. doi: 10.1002/cre2.395. Epub 2021 Feb 9.

  PMID: 33565266 BACKGROUND

• Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.

  PMID: 18584934 BACKGROUND

• Tripathi B, Manjunath RGS, Garg J, Gokhale ST, Nagate RR, Nishant K, Al-Qahtani SM, Al Magbol M, Tikare S, Chaturvedi M, Al-Qarni MA, Elagib MFA, Javali MA, Chaturvedi S. PRF membrane vs. chorion membrane with coronally advanced flap: a clinical study on gingival recession. Odontology. 2026 Jan 17. doi: 10.1007/s10266-026-01312-8. Online ahead of print.

  PMID: 41545633 DERIVED

MeSH Terms

Conditions

Gingival Recession

Interventions

Tissue Banks

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Shatyajit Naik, MDS

  Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor-primary Investigator

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 29, 2025
• Study Start: December 4, 2015
• Primary Completion: May 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: it is completed
• Access Criteria: statician will acess the information for statistical analysis

Locations

IN (1)