Effect of Injectable Platelet-rich Fibrin (i-PRF) on Wound Healing After Gingivectomy

NCT07785349 | Completed

• 2 other identifiers: Sude14082022/120
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the clinical and biochemical effects of injectable platelet-rich fibrin (i-PRF) on wound healing after gingivectomy, a surgical procedure used to treat gingival overgrowth. Using a split-mouth design, i-PRF was applied to the surgical site on one side of the mouth (test group), while the other side was treated with conventional gingivectomy alone, without any additional material (control group). Clinical periodontal parameters (plaque index, gingival index, probing depth, clinical attachment level, and bleeding on probing) were assessed at baseline, before surgery, and 28 days after surgery. Additionally, levels of PDGF, IGF-1, and IL-18 in gingival crevicular fluid were measured before surgery and on the third postoperative day to evaluate the biochemical impact of i-PRF on wound healing. A total of 31 participants aged 15-50 years were included in the study.

Conditions

Gingival Overgrowth; Gingival Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change in Gingival Crevicular Fluid (GCF) IL-18, IGF-1 and PDGF Levels

  Immediately before surgery (baseline) and postoperative day 3

Study Arms (2)

i-PRF Group

EXPERIMENTAL

In this split-mouth designed study, the right side of the jaw served as the test site. Following conventional gingivectomy, injectable platelet-rich fibrin (i-PRF) was applied to the surgical wound before placement of the periodontal dressing.

Biological: injectable Platelet-Rich Fibrin (i-PRF); Procedure: Conventional Gingivectomy

Control Group

OTHER

In this split-mouth designed study, the left side of the jaw served as the control site. Conventional gingivectomy was performed and periodontal dressing was placed, without application of any additional material to the wound site.

Procedure: Conventional Gingivectomy

Interventions

injectable Platelet-Rich Fibrin (i-PRF) BIOLOGICAL

Autologous injectable platelet-rich fibrin, prepared by centrifugation of the patient's own venous blood, applied directly to the gingivectomy wound site.

Also known as: gingivectomy

i-PRF Group

Conventional Gingivectomy PROCEDURE

Standard surgical excision of overgrown gingival tissue using periodontal knives.

Control Group; i-PRF Group

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Presence of bilateral, symmetric chronic inflammatory gingival overgrowth in the anterior mandibular or maxillary region
• Absence of attachment loss and bone loss at the surgical site
• Absence of systemic conditions that could affect wound healing and periodontal surgical outcomes, such as uncontrolled diabetes, cancer, HIV, or metabolic bone diseases
• No use of systemic corticosteroids, immunosuppressive agents, radiotherapy, and/or chemotherapy prescribed or taken within 2 months prior to the study intervention, which could affect study outcomes, wound healing, and the coagulation mechanism
• Normal physiological hormonal balance

You may not qualify if:

• Patients unable to achieve optimal oral hygiene or with poor compliance/communication
• Presence of any systemic disease adversely affecting periodontal health and post-procedural wound healing (e.g., diabetes, rheumatoid arthritis, neurological disorders, pulmonary and renal diseases)
• Use of medications known to cause gingival overgrowth, including immunosuppressants, anticonvulsants, and calcium channel blockers
• Pregnancy or lactation in female participants
• Presence of moderate to advanced gingivitis or periodontitis
• Current smoking

Sponsors & Collaborators

• Şeyma Çardakçı: lead
• Afyonkarahisar Health Sciences University: collaborator

Study Sites (1)

Afyonkarahisar Health Sciences University, Faculty of Dentistry

Ankara, None Selected, 06220, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Overgrowth; Gingival Hyperplasia

Interventions

proliferation regulatory factors, human urine; Gingivectomy

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Periodontics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Model Details: In this split-mouth study, the contralateral side (right) received conventional gingivectomy followed by application of injectable platelet-rich fibrin (i-PRF) to the wound site.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: September 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)