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

NCT ID: NCT07308405

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-04
• Study Completion Date: 2016-10-31

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.

Detailed Description

Platelet-rich fibrin (PRF), a second-generation platelet concentrate, accelerates soft and hard tissue regeneration. Chorion membrane, of fetal origin, has wound-modulating properties. This study aimed to evaluate and compare the clinical outcomes of PRF and chorion membrane in treating isolated Miller's Class I or II gingival recession defects. Fifty recession defects in 50 patients were randomly treated with a coronally advanced flap (CAF) and PRF membrane (site A, n = 25) or CAF with chorion membrane (site B, n = 25). Clinical parameters recorded at baseline, 1, 3, and 6 months included recession depth (RD), recession width (RW), clinical attachment level (CAL), width of keratinised gingiva (WKG), plaque index (PI), gingival index (GI), and gingival biotype. Statistical analysis compared outcomes across follow-up intervals. At six months, both groups demonstrated significant improvements in RD, RW, CAL, WKG, PI, and GI compared with baseline. Mean percentage root coverage was 86.76 ± 13.76 in the PRF group and 82.89 ± 15.65 in the chorion group, with no statistically significant difference between them. Sites with an initial thin biotype showed conversion to a thick biotype in both groups. Both PRF and chorion membrane demonstrated predictable effectiveness for managing isolated recession defects, with comparable outcomes. Longitudinal studies are needed to confirm these findings.

Conditions

Gingival Recession

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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 B: patient were treated with coronally advanced flap (CAF) and CM

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

OTHER

Sponsor Role: lead

Responsible Party

Bimmi Tripathi

Doctor-primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shatyajit Naik, MDS

Role: STUDY_CHAIR

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Locations

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

Bareilly, Uttar Pradesh, India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 33565266 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18584934 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

IDS/ETHCC/14/08

Identifier Type: -

Identifier Source: org_study_id