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Completed

NCT Number: NCT07785349

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

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.

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Key information

Conditions

Gingival Overgrowth Gingival Diseases Gingival Hyperplasia Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Health Sciences University, Faculty of Dentistry

Ankara, None Selected, 06220, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Achieving an optimal level of oral hygiene following Phase I periodontal therapy

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Other names: gingivectomy

Conventional Gingivectomy

Procedure

Standard surgical excision of overgrown gingival tissue using periodontal knives.

Primary outcomes

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

    Time frame: Immediately before surgery (baseline) and postoperative day 3

Sponsors and collaborators

Lead sponsor

Şeyma Çardakçı

Other

Collaborators

  • Afyonkarahisar Health Sciences University

Registry information

Official study title

Clinical and Biochemical Evaluation of the Effect of Injectable Platelet-rich Fibrin Applied to the Operation Site After Gingivectomy

Acronym: i-PRF-GIN

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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