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Completed

NCT Number: NCT07308405

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

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bareilly, Uttar Pradesh, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Recession depth (RD)

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

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

  2. Recession width (RW)

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

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

  3. Clinical attachment level (CAL)

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

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

  4. Width of keratinized gingiva (WKG)

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

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

  5. Assessment of gingival biotype

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

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

Sponsors and collaborators

Lead sponsor

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Other

Registry information

Official study title

Comparative Clinical Evaluation of Coronally Advanced Flap With Platelet Rich Fibrin Membrane and Chorion Membrane in the Treatment of Human Gingival Recession

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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