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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: injectable Platelet-Rich Fibrin (i-PRF)
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
Procedure: Conventional Gingivectomy
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.
Procedure: Conventional Gingivectomy
Standard surgical excision of overgrown gingival tissue using periodontal knives.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Şeyma Çardakçı

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Afyonkarahisar Health Sciences University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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