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Evaluation of the Effects of I-PRF and C-PRF on Gingival Phenotype

I

Inonu University

Status

Completed

Conditions

Thin Gingiva
Thin Gingival Biotype

Treatments

Biological: Concentrated PRF
Biological: Injectable PRF

Study type

Interventional

Funder types

Other

Identifiers

NCT06964529
2024/74 - PRF

Details and patient eligibility

About

This clinical trial aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF) and concentrated platelet-rich fibrin (C-PRF) on gingival phenotype in patients undergoing mucogingival surgery with the VISTA technique. Changes in gingival thickness and width of keratinized gingiva will be assessed using both manual and digital methods.

Full description

The study is designed as a randomized controlled clinical trial including 30 patients, divided into two groups: I-PRF and C-PRF. All participants receive a mucogingival procedure using the VISTA technique followed by four sessions of PRF injections (one during surgery and three at 10-day intervals). The primary outcomes are changes in gingival thickness and the width of keratinized gingiva, measured manually and digitally at baseline, 1 month, 3 months and 6 months. The aim is to compare the effectiveness of I-PRF and C-PRF on soft tissue enhancement.

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Systemically healthy individuals (ASA I) Age between 18 and 45 years Non-smokers Gingival thickness ≤ 0.8 mm in the mandibular anterior region No restorations, missing teeth, or supernumerary teeth in the mandibular anterior region Full-mouth plaque index (PI) < 15% Full-mouth bleeding on probing (BOP) < 15%

Exclusion criteria

Presence of systemic disease or coagulation disorders Use of antibiotics or anti-inflammatory drugs within the last 3 months Smoking History of bruxism Pregnancy or lactation Ongoing orthodontic treatment Use of medications affecting gingival phenotype (e.g., calcium channel blockers, anticonvulsants) Presence of infection, lesion, or trauma at the surgical site History of periodontal surgery in the relevant area

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

C-PRF Group
Experimental group
Description:
Concentrated platelet-rich fibrin was prepared using horizontal centrifugation and injected at 4 time points (once during the VISTA procedure, and 3 additional times at 10-day intervals).
Treatment:
Biological: Concentrated PRF
I-PRF Group
Experimental group
Description:
Injectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions).
Treatment:
Biological: Injectable PRF

Trial contacts and locations

1

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Central trial contact

UMMU GULSUM OGE, RA

Data sourced from clinicaltrials.gov

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