i-PRF for Gingival Phenotype Modification

Gingival Phenotype Thickening Using Injectable PRF Alone or Combined With a Semi-Surgical Approach: A Split-Mouth Study

This randomized split-mouth clinical trial aims to evaluate the effectiveness of injectable platelet-rich fibrin (i-PRF) in thickening thin gingival phenotype and improving soft tissue conditions around teeth.

Thin gingival tissue is an important risk factor for gingival recession and may negatively affect periodontal health and esthetic outcomes. This study investigates whether the use of i-PRF, obtained from the patient's own blood, can enhance gingival thickness and support tissue healing.

Following initial periodontal therapy, the procedure will be performed under local anesthesia. A minimally invasive approach will be applied to the gingival tissue, and i-PRF prepared from the patient's blood will be injected into the treatment area. The procedure will be repeated in multiple sessions at regular intervals. Patients will receive standard post-operative care and instructions.

Clinical parameters will be evaluated at follow-up visits, and gingival thickness will be measured using ultrasonography over a 6-month period.

Possible risks include mild pain, bleeding, infection, and temporary discomfort, all of which are manageable with routine clinical care.

This study is expected to contribute to the development of minimally invasive and biologically based treatment approaches, reduce the need for additional surgical procedures, and improve periodontal and esthetic outcomes.

Study Overview

• Status: Active, not recruiting
• Conditions: Thin Gingival Biotype
• Intervention / Treatment: Procedure: Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Çanakkale, Turkey (Türkiye)
    • Canakkale Onsekiz Mart University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Systemically healthy individuals aged ≥18 years
• Non-smokers or light smokers (≤10 cigarettes per day)
• Individuals with full-mouth plaque score (FMPS) <15% and full-mouth bleeding score (FMBS) <15%
• Individuals with gingival thickness <0.8 mm in the mandibular anterior teeth to be treated
• Periodontally healthy individuals with probing depth (PD) ≤3 mm in the mandibular anterior teeth
• Absence of structural defects, crowns, or large restorations in the mandibular anterior teeth
• Absence of missing or supernumerary teeth in the mandibular anterior region
• No history of blood-borne infectious diseases
• No systemic diseases or medical conditions

Exclusion Criteria:

• Individuals under 18 years of age
• Pregnancy or breastfeeding
• Presence of periodontal pockets >4 mm
• Presence of structural defects, crowns, or large restorations in the teeth
• Presence of systemic diseases or coagulation disorders
• Use of anticoagulant medications
• Ongoing orthodontic treatment with active tooth movement
• Use or history of medications affecting periodontal tissues (e.g., immunosuppressive drugs, calcium channel blockers, anticonvulsants)
• History of periodontal surgery in the area to be treated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Injectable Platelet-Rich Fibrin (i-PRF) Alone (control)	Procedure: Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique; Injectable platelet-rich fibrin (i-PRF) will be prepared from the participant's venous blood using a low-speed centrifugation protocol without anticoagulants. The obtained liquid fibrin will be applied to gingival tissues with a thin phenotype. After initial periodontal therapy, the procedure will be performed under local anesthesia using a minimally invasive semi-surgical approach. A small apical incision and gentle periosteal elevation will be performed to create space, followed by injection of i-PRF into the target area using a dental syringe. The procedure will be repeated at 10-day intervals for a total of four sessions. This intervention aims to enhance gingival thickness and improve soft tissue quality through the biological effects of autologous platelet concentrates, including growth factor release and angiogenesis.
Active Comparator: Injectable Platelet-Rich Fibrin (i-PRF) with Minimally Invasive Technique (test)	Procedure: Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique; Injectable platelet-rich fibrin (i-PRF) will be prepared from the participant's venous blood using a low-speed centrifugation protocol without anticoagulants. The obtained liquid fibrin will be applied to gingival tissues with a thin phenotype. After initial periodontal therapy, the procedure will be performed under local anesthesia using a minimally invasive semi-surgical approach. A small apical incision and gentle periosteal elevation will be performed to create space, followed by injection of i-PRF into the target area using a dental syringe. The procedure will be repeated at 10-day intervals for a total of four sessions. This intervention aims to enhance gingival thickness and improve soft tissue quality through the biological effects of autologous platelet concentrates, including growth factor release and angiogenesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Thickness (Ultrasonographic Measurement)	Assessment of gingival thickness using ultrasonography to evaluate changes in soft tissue thickness. Measurements will be performed at baseline, 1 month, 3 months, and 6 months.	6 month

Collaborators and Investigators

• Sponsor: Çanakkale Onsekiz Mart University

Publications and helpful links

General Publications

• Ozsagir ZB, Saglam E, Sen Yilmaz B, Choukroun J, Tunali M. Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):489-499. doi: 10.1111/jcpe.13247. Epub 2020 Feb 11.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: i-PRF; VISTA technique; Gingival thickness; Gingival Phenotype
• Additional Relevant MeSH Terms: proliferation regulatory factors, human urine
• Other Study ID Numbers: OGU-EC-06-25; 2024-KAEK-15 (Other Identifier: Turkish Medicines and Medical Devices Agency (TİTCK))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No