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

I

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Status

Completed

Conditions

Gingival Recession

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07308405
IDS/ETHCC/14/08

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Experimental site A: patient were treated with coronally advanced flap and PRF
Experimental group
Description:
Twenty five sites in each of 25 patient were treated with coronally advanced flap (CAF) and platelet-rich fibrin (PRF) membrane;
Treatment:
Procedure: Coronally advanced flap (CAF) with platelet-rich fibrin (PRF)
Experimental site B: patient were treated with coronally advanced flap (CAF) and CM
Experimental group
Description:
Twenty five sites in each of other 25 patient were treated with coronally advanced flap (CAF) and chorion membrane (CM)
Treatment:
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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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