- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07308405
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
50
Phase
- 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
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Uttar Pradesh
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Bareilly, Uttar Pradesh, India
- Department of Periodontics and implantology , Institute of Dental sciences, Bareilly, Uttar Pradesh, India
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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
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 |
Intervention / Treatment |
|---|---|
|
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;
|
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.
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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)
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What is the study measuring?
Primary Outcome Measures
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
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Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
|
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Recession width (RW)
Time Frame: Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
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Measured between mesial and distal papillae across the buccal surface at the CEJ level
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Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
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|
Clinical attachment level (CAL)
Time Frame: Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits:
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Measured from the CEJ to the bottom of the gingival sulcus;
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Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits:
|
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Width of keratinized gingiva (WKG)
Time Frame: Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
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Measured from the gingival margin to the mucogingival junction (MGJ)
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Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
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Assessment of gingival biotype
Time Frame: Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
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Evaluated based on the transparency of the probe through the gingival margin while probing the sulcus at the midfacial aspect of teeth
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Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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
- 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.
- 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.
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)
December 4, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
November 22, 2025
First Submitted That Met QC Criteria
December 19, 2025
First Posted (Actual)
December 29, 2025
Study Record Updates
Last Update Posted (Actual)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 19, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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