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

December 19, 2025 updated by: Bimmi Tripathi, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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;
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.
Experimental: 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)
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
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
Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
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;
Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits:
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)
Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
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
Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Shatyajit Naik, MDS, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IDS/ETHCC/14/08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the clinical mesurement values were shared for statistical analysis

IPD Sharing Time Frame

it is completed

IPD Sharing Access Criteria

statician will acess the information for statistical analysis

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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