i-PRF for Gingival Phenotype Modification

NCT07521527 | Active Not Recruiting

• 2 other identifiers: OGU-EC-06-252024-KAEK-15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thin Gingival Biotype

Keywords

i-PRF; VISTA technique; Gingival Phenotype; Gingival thickness

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Injectable Platelet-Rich Fibrin (i-PRF) Alone (control)

ACTIVE COMPARATOR

Procedure: Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique

Injectable Platelet-Rich Fibrin (i-PRF) with Minimally Invasive Technique (test)

ACTIVE COMPARATOR

Procedure: Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique

Interventions

Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique PROCEDURE

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.

Injectable Platelet-Rich Fibrin (i-PRF) Alone (control); Injectable Platelet-Rich Fibrin (i-PRF) with Minimally Invasive Technique (test)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Çanakkale Onsekiz Mart University

Çanakkale, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 31912532 BACKGROUND

MeSH Terms

Interventions

proliferation regulatory factors, human urine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)