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

Not Applicable

Recruiting

• Conditions: Gingival Phenotype; Width of Keratinized Gingiva; Periodontal Soft Tissue
• Interventions: Biological: Concentrated PRF; Biological: Injectable PRF

• Registration Number: NCT06964529
• Lead Sponsor: Inonu University

Brief Summary

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

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.

Study Timeline

• Study Start: 2025-02-11
• Status Verified: 2025-05
• Study First Submitted: 2025-05-01
• Study First Submitted QC: 2025-05-01
• Last Update Submitted: 2025-05-01
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Primary Completion: 2025-07-15
• Study Completion: 2025-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C-PRF Group	Concentrated PRF	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).
I-PRF Group	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).

Primary Outcome Measures

Name	Time	Method
Change in gingival thickness	Baseline, 1 month, 3 months	Gingival thickness will be measured both manually (using a spreader) and digitally (via STL-PLY file superimposition) to assess the effect of I-PRF and C-PRF over time.

Secondary Outcome Measures

Name	Time	Method
Change in width of keratinized gingiva	Baseline, 1 month, 3 months	The width of keratinized gingiva will be measured manually using a periodontal probe to evaluate the soft tissue augmentation potential of C-PRF and I-PRF.

Trial Locations

Locations (1)

Inonu University Faculty of Dentistry; 🇹🇷 Malatya, Turkey