Gingival RecessionNCT07308405
Evaluating Coronally Advanced Flap With Platelet-rich Fibrin Membrane and Chorion Membrane for Gingival Recession
A study testing Coronally advanced flap (CAF) with platelet-rich fibrin (PRF) and 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 in people with Gingival Recession, run by Institute of Dental Sciences, Bareilly, Uttar Pradesh, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Coronally advanced flap (CAF) with platelet-rich fibrin (PRF) and 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 4 Dec 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Periodontics and implantology , Institute of Dental sciences, Bareilly, Uttar Pradesh, India
Bareilly, Uttar Pradesh
About this study
Official title: 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.
Read the 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
- Being tested
- Coronally advanced flap (CAF) with platelet-rich fibrin (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
- Keywords
- Coronally advanced flap, platelet rich fibrin, root coverage, chorion membrane, Gingival Recession Localized Moderate
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally advanced flap (CAF) with platelet-rich fibrin (PRF)Procedure or surgery
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) oProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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) Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
Recession depth (RD)
Measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin
Measured: 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
Measured: 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;
Measured: 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)
Measured: 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
Measured: Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start4 Dec 2015
- Primary completionMay 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bimmi Tripathi, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
- Investigators
- Shatyajit Naik, MDS, Study chair, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308405
- Sponsor's protocol ID
- IDS/ETHCC/14/08
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the clinical mesurement values were shared for statistical analysis
Publications
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.
PubMed 33565266Chambrone 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.
PubMed 18584934Tripathi 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.
PubMed 41545633
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Evaluation of Coronally Advanced Flap With Platelet Rich Fibrin Membrane and Chorion Membrane in the Treatment of Human Gingival Recession
- ClinicalTrials.gov ID
- NCT07308405
- Acronym / sponsor ID
- IDS/ETHCC/14/08
- Conditions
- Gingival Recession
- Keywords
- Coronally advanced flap, platelet rich fibrin, root coverage, chorion membrane, Gingival Recession Localized Moderate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institute of Dental Sciences, Bareilly, Uttar Pradesh, IndiaUniversity, hospital or other
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental site A: patient were treated with coronally advanced flap and PRF | Experimental | Procedure: Coronally advanced flap (CAF) with platelet-rich fibrin (PRF)Twenty five sites in each of 25 patient were treated with coronally advanced flap (CAF) and platelet-rich fibrin (PRF) membrane; |
| Experimental site B: patient were treated with coronally advanced flap (CAF) and CM | Experimental | 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) oTwenty five sites in each of other 25 patient were treated with coronally advanced flap (CAF) and chorion membrane (CM) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- Poor oral hygiene after Phase I therapy
- Smoking or alcohol use
- Occlusal disharmony
- Parafunctional habits
- Non-vital or endodontically treated teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | 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 or surgery | Experimental site B: patient were treated with coronally advanced flap (CAF) and CM |
Primary outcome
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
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
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;
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 33565266Bertl 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.
- Background: PubMed 18584934Chambrone 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.
- Derived from this study: PubMed 41545633Tripathi 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.
- Individual participant dataSharing planned: Yes. the clinical mesurement values were shared for statistical analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shatyajit Naik, MDS study chair
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronally advanced flap (CAF) with platelet-rich fibrin (PRF) and 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 in people with Gingival Recession, run by Institute of Dental Sciences, Bareilly, Uttar Pradesh, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession depth (RD) (time frame: Baseline, prior to surgery and at 1 month, 3 months and 6 months follow-up visits). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07308405, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.