- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07785349
Effect of Injectable Platelet-rich Fibrin (i-PRF) on Wound Healing After Gingivectomy (i-PRF-GIN)
August 21, 2026 updated by: Şeyma Çardakçı
Clinical and Biochemical Evaluation of the Effect of Injectable Platelet-rich Fibrin Applied to the Operation Site 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
None Selected
-
Ankara, None Selected, Turkey (Türkiye), 06220
- Afyonkarahisar Health Sciences University, Faculty of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: i-PRF Group
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.
|
Autologous injectable platelet-rich fibrin, prepared by centrifugation of the patient's own venous blood, applied directly to the gingivectomy wound site.
Other Names:
Standard surgical excision of overgrown gingival tissue using periodontal knives.
|
|
Other: Control Group
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.
|
Standard surgical excision of overgrown gingival tissue using periodontal knives.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Gingival Crevicular Fluid (GCF) IL-18, IGF-1 and PDGF Levels
Time Frame: Immediately before surgery (baseline) and postoperative day 3
|
Immediately before surgery (baseline) and postoperative day 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
August 21, 2026
First Submitted That Met QC Criteria
August 21, 2026
First Posted (Actual)
August 25, 2026
Study Record Updates
Last Update Posted (Actual)
August 25, 2026
Last Update Submitted That Met QC Criteria
August 21, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sude1408
- 2022/120 (Other Identifier: Afyonkarahisar Health Sciences University Clinical Research Ethics Committee (2011-KAEK-2))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.