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

NCT ID: NCT06964529

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-11

Study Completion Date

2025-08-10

Brief Summary

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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.

Detailed Description

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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, and 3 months. The aim is to compare the effectiveness of I-PRF and C-PRF on soft tissue enhancement.

Conditions

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Gingival Phenotype Periodontal Soft Tissue Width of Keratinized Gingiva

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm parallel design comparing the effects of I-PRF and C-PRF on gingival phenotype using VISTA technique.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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C-PRF Group

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).

Group Type EXPERIMENTAL

Concentrated PRF

Intervention Type BIOLOGICAL

Injectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions at 10-day intervals).

I-PRF Group

Injectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions).

Group Type EXPERIMENTAL

Injectable PRF

Intervention Type BIOLOGICAL

Injectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions at 10-day intervals).

Interventions

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Concentrated PRF

Injectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions at 10-day intervals).

Intervention Type BIOLOGICAL

Injectable PRF

Injectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions at 10-day intervals).

Intervention Type BIOLOGICAL

Other Intervention Names

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C-PRF I-PRF

Eligibility Criteria

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Inclusion Criteria

Systemically healthy individuals aged 18-65 years No periodontal surgery in the last 6 monthsClinically healthy periodontium (no signs of active periodontal disease) Patient compliance and consent to participate

Exclusion Criteria

Smoking Pregnancy or lactation Systemic diseases affecting healing (e.g., diabetes, immunosuppression) Use of anticoagulants or medications affecting soft tissue Poor oral hygiene or noncompliance
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Ümmü Gülsüm ÖĞE

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Inonu University Faculty of Dentistry

Malatya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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UMMU GULSUM OGE, RA

Role: CONTACT

05354404315

Facility Contacts

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Ümmü Gülsüm ÖĞE, RA

Role: primary

05354404315

Other Identifiers

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2024/74

Identifier Type: -

Identifier Source: org_study_id

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