Gingival Overgrowthi-PRF-GINNCT07785349
Effect of Injectable Platelet-rich Fibrin (i-PRF) on Wound Healing After Gingivectomy
A study testing injectable Platelet-Rich Fibrin (i-PRF) and Conventional Gingivectomy in people with Gingival Overgrowth and Gingival Hyperplasia, run by Şeyma Çardakçı at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Overgrowth, Gingival Hyperplasia
- What is being tested?
- injectable Platelet-Rich Fibrin (i-PRF) and Conventional Gingivectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University, Faculty of Dentistry
Ankara, None Selected, 06220
About this study
Official title: 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.
- Conditions
- Gingival Overgrowth, Gingival Hyperplasia
- Being tested
- injectable Platelet-Rich Fibrin (i-PRF), Conventional Gingivectomy
- Medical subject headings
- Gingival Overgrowth, Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable Platelet-Rich Fibrin (i-PRF)Biological
Also called gingivectomy
Autologous injectable platelet-rich fibrin, prepared by centrifugation of the patient's own venous blood, applied directly to the gingivectomy wound site.
Conventional GingivectomyProcedure or surgery
Standard surgical excision of overgrown gingival tissue using periodontal knives.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Gingivectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Crevicular Fluid (GCF) IL-18, IGF-1 and PDGF Levels
Measured: Immediately before surgery (baseline) and postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2022
- Primary completion1 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival OvergrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şeyma Çardakçı
- Sponsor type
- University, hospital or other
- Collaborators
- Afyonkarahisar Health Sciences University
- Responsible party
- Sponsor-investigator, Şeyma Çardakçı, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785349
- Sponsor's protocol ID
- Sude1408
- Other IDs
- 2022/120
- Acronym
- i-PRF-GIN
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation of the Effect of Injectable Platelet-rich Fibrin Applied to the Operation Site After Gingivectomy
- ClinicalTrials.gov ID
- NCT07785349
- Acronym / sponsor ID
- i-PRF-GIN / Sude1408
- Conditions
- Gingival Overgrowth, Gingival Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Şeyma ÇardakçıUniversity, hospital or other
- Collaborators
- Afyonkarahisar Health Sciences University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| i-PRF Group | Experimental | Biological: injectable Platelet-Rich Fibrin (i-PRF), Procedure: Conventional GingivectomyIn 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. |
| Control Group | Other | Procedure: Conventional GingivectomyIn 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. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injectable Platelet-Rich Fibrin (i-PRF)Also: gingivectomyAutologous injectable platelet-rich fibrin, prepared by centrifugation of the patient's own venous blood, applied directly to the gingivectomy wound site. | Biological | i-PRF Group |
| Conventional GingivectomyStandard surgical excision of overgrown gingival tissue using periodontal knives. | Procedure or surgery | Control Group, i-PRF Group |
Primary outcome
Change in Gingival Crevicular Fluid (GCF) IL-18, IGF-1 and PDGF Levels
Time frame: Immediately before surgery (baseline) and postoperative day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes
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The Effect of Ozone Therapy on Gingivoplasty
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Periodontal Plastic Reconstruction of Soft Tissue Dehiscences After the Removal of Localized Gingival Enlargements
Localized Gingival Enlargement, Epulides
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injectable Platelet-Rich Fibrin (i-PRF) and Conventional Gingivectomy in people with Gingival Overgrowth and Gingival Hyperplasia, run by Şeyma Çardakçı at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gingival Crevicular Fluid (GCF) IL-18, IGF-1 and PDGF Levels (time frame: Immediately before surgery (baseline) and postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.