NCT06964529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

May 1, 2025

Last Update Submit

March 23, 2026

Conditions

Keywords

C-PRFI-PRFVISTA Technique

Outcome Measures

Primary Outcomes (1)

  • Change in gingival thickness

    Gingival thickness will be measured manually (using a spreader) to assess the effect of I-PRF and C-PRF over time.

    Baseline, 1 month, 3 months and 6 months.

Secondary Outcomes (1)

  • Change in width of keratinized gingiva

    Baseline, 1 month, 3 months and 6 months

Study Arms (2)

C-PRF Group

EXPERIMENTAL

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).

Biological: Concentrated PRF

I-PRF Group

EXPERIMENTAL

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

Biological: Injectable PRF

Interventions

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).

Also known as: C-PRF
C-PRF Group
Injectable PRFBIOLOGICAL

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).

Also known as: I-PRF
I-PRF Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Faculty of Dentistry

Malatya, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm parallel design comparing the effects of I-PRF and C-PRF on gingival phenotype using VISTA technique.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 1, 2025

First Posted

May 9, 2025

Study Start

February 11, 2025

Primary Completion

July 15, 2025

Study Completion

August 10, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations