PeriodontitisPRF-NSPTNCT07525531
Effects of PRF and i-PRF on Clinical and Biochemical Parameters in Non-Surgical Periodontal Therapy
A study testing Non-surgical periodontal therapy (NSPT), Platelet-rich fibrin (PRF) and Injectable platelet-rich fibrin (i-PRF) in people with Periodontitis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if adding platelet-rich fibrin (PRF) or injectable platelet-rich fibrin (i-PRF), obtained from the participant's own blood, to standard non-surgical periodontal treatment helps improve gum health in individuals with periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Non-surgical periodontal therapy (NSPT), Platelet-rich fibrin (PRF) and Injectable platelet-rich fibrin (i-PRF)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2024to 25 Dec 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary consent to participate in the study
- Individuals aged 18 years or older
- Systemically healthy individuals
- Abstaining from the use of any drugs for any purpose
- No periodontal treatment history in the past six months
- Individuals who do not smoke
Who cannot join
- Absence of willingness to engage in the studies
- Individuals under the age of 18
- Existence of any systemic disease influencing periodontal condition and consistent medication usage
- Administration of local or systemic antibiotics within the preceding six months
- Chronicle of periodontal therapy during the past six months
- History of any periodontal surgical intervention within the past 12 months
- Pregnancy or lactation in female subjects
- Teeth with endodontic lesion or mobility degrees 2 and 3
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University
Samsun, Atakum, 55200
About this study
Official title: The Effects of Adjunctive PRF and i-PRF Applications on GCF Levels of IL-1ß, TNF-α, IL-6, OPG and RANKL in Non-surgical Periodontal Therapy
The goal of this clinical trial is to learn if adding platelet-rich fibrin (PRF) or injectable platelet-rich fibrin (i-PRF), obtained from the participant's own blood, to standard non-surgical periodontal treatment helps improve gum health in individuals with periodontitis. It will also assess how these applications affect inflammation and bone-related markers in the gum fluid. The main questions it aims to answer are :
- Does the application of PRF or i-PRF improve clinical periodontal healing compared to standard treatment alone?
- Do these applications influence the levels of inflammatory and bone metabolism-related biomarkers in gingival crevicular fluid? Researchers will compare patients receiving PRF or i-PRF in addition to standard periodontal treatment with those receiving standard treatment alone. In addition, the findings obtained from individuals with periodontal disease will be compared with data from periodontally healthy individuals.
Read more
Participants will:
- Receive standard periodontal treatment (scaling and root planing)
- Receive PRF or i-PRF depending on their assigned group
- Visit the clinic before treatment and at 2, 4, and 6 weeks after treatment for checkups
Read the detailed description
his study was designed as a randomized controlled clinical trial to evaluate the adjunctive effects of platelet-rich fibrin (PRF) and injectable platelet-rich fibrin (i-PRF) in individuals with periodontitis undergoing non-surgical periodontal therapy (NSPT).
A total of 56 participants were included in the study, comprising 42 systemically healthy patients diagnosed with periodontitis and 14 systemically and periodontally healthy individuals serving as controls. Periodontitis patients were randomly allocated into three treatment groups using a sealed-envelope method: NSPT alone (scaling and root planing, SRP), NSPT with adjunctive PRF application, and NSPT with adjunctive i-PRF application.
PRF and i-PRF were prepared from autologous venous blood obtained from the participants and were applied locally into periodontal pockets immediately following SRP.
Clinical periodontal parameters were recorded at baseline and at the 2nd, 4th, and 6th weeks following treatment. Gingival crevicular fluid (GCF) samples were collected at baseline and at the 2nd and 6th weeks. The levels of inflammatory cytokines (IL-1β, TNF-α, IL-6) and bone metabolism-related biomarkers (OPG and RANKL) in GCF were quantified using enzyme-linked immunosorbent assay (ELISA).
The findings of this study provided insight into the potential clinical and biochemical benefits of PRF and i-PRF as adjunctive approaches in NSPT and allowed comparison with periodontally healthy conditions.
- Conditions
- Periodontitis
- Being tested
- Non-surgical periodontal therapy (NSPT), Platelet-rich fibrin (PRF), Injectable platelet-rich fibrin (i-PRF)
- Keywords
- Periodontitis, Platelet Rich Fibrin, Non-Surgical Periodontal Therapy, Gingival Crevicular Fluid, IL-1ß, TNF-α, IL-6, OPG, RANKL
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal therapy (NSPT)Procedure or surgery
Non-surgical periodontal therapy (NSPT) consisted of full-mouth scaling and root planing (SRP), including the removal of supra- and subgingival deposits using ultrasonic devices and hand instruments.
Platelet-rich fibrin (PRF)Biological
Platelet-rich fibrin (PRF) was prepared from autologous venous blood by centrifugation at 2700 rpm for 12 minutes, processed into a membrane, adapted to the size of the periodontal pocket, and placed into the periodontal pocket using hand instruments.
Injectable platelet-rich fibrin (i-PRF)Biological
Injectable platelet-rich fibrin (i-PRF) was prepared from autologous venous blood by low-speed centrifugation at 700 rpm for 3 minutes and injected into periodontal pockets.
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical periodontal therapy (NSPT) | Active comparator | Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). No adjunctive biomaterial was applied. Receives: Procedure: Non-surgical periodontal therapy (NSPT) |
| NSPT + PRF | Experimental | Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, platelet-rich fibrin (PRF) was applied into periodontal pockets. Receives: Procedure: Non-surgical periodontal therapy (NSPT); Biological: Platelet-rich fibrin (PRF) |
| NSPT + i-PRF | Experimental | Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, injectable platelet-rich fibrin (i-PRF) was applied into periodontal pockets. Receives: Procedure: Non-surgical periodontal therapy (NSPT); Biological: Injectable platelet-rich fibrin (i-PRF) |
| Healthy control | No intervention | Periodontally and systemically healthy participants were included as controls. No periodontal treatment was performed. Gingival crevicular fluid (GCF) samples were collected, and oral hygiene instructions were provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in probing depth (PD)
Change in probing depth (PD) measured in millimeters at six sites per tooth using a periodontal probe, comparing baseline values with follow-up measurements.
Measured: Baseline, 2 weeks, 4 weeks, and 6 weeks
Secondary outcomes (9)
Change in clinical attachment level (CAL)
Change in clinical attachment level (CAL) measured in millimeters at six sites per tooth using a periodontal probe, comparing baseline and follow-up measurements.
Measured: Baseline, 2 weeks, 4 weeks, and 6 weeks
Change in plaque index (PI)
Change in plaque index (PI) scores assessed at baseline and during follow-up visits.
Measured: Baseline, 2 weeks, 4 weeks, and 6 weeks
Change in gingival index (GI)
Change in gingival index (GI) scores evaluated at baseline and follow-up visits.
Measured: Baseline, 2 weeks, 4 weeks, and 6 weeks
Change in bleeding on probing (BoP)
Change in bleeding on probing (BoP) assessed at six sites per tooth at baseline and follow-up visits.
Measured: Baseline, 2 weeks, 4 weeks, and 6 weeks
Change in gingival crevicular fluid (GCF) IL-1β levels
Change in IL-1β levels in gingival crevicular fluid measured using ELISA.
Measured: Baseline, 2 weeks, and 6 weeks
Change in gingival crevicular fluid (GCF) TNF-α levels
Change in TNF-α levels in gingival crevicular fluid measured using ELISA.
Measured: Baseline, 2 weeks, and 6 weeks
Change in gingival crevicular fluid (GCF) IL-6 levels
Change in IL-6 levels in gingival crevicular fluid measured using ELISA.
Measured: Baseline, 2 weeks, and 6 weeks
Change in gingival crevicular fluid (GCF) OPG levels
Change in OPG levels in gingival crevicular fluid measured using ELISA.
Measured: Baseline, 2 weeks, and 6 weeks
Change in gingival crevicular fluid (GCF) RANKL levels
Change in RANKL levels in gingival crevicular fluid measured using ELISA.
Measured: Baseline, 2 weeks, and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 Apr 2024
- Primary completion5 Aug 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IREM OZCEYLAN, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525531
- Sponsor's protocol ID
- OMU-KAEK- 2023/344
- Other IDs
- BAP04-B-2024-5249
- Acronym
- PRF-NSPT
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Adjunctive PRF and i-PRF Applications on GCF Levels of IL-1ß, TNF-α, IL-6, OPG and RANKL in Non-surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT07525531
- Acronym / sponsor ID
- PRF-NSPT / OMU-KAEK- 2023/344
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Platelet Rich Fibrin, Non-Surgical Periodontal Therapy, Gingival Crevicular Fluid, IL-1ß, TNF-α, IL-6, OPG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 13 Apr 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.
The goal of this clinical trial is to learn if adding platelet-rich fibrin (PRF) or injectable platelet-rich fibrin (i-PRF), obtained from the participant's own blood, to standard non-surgical periodontal treatment helps improve gum health in individuals with periodontitis. It will also assess how these applications affect inflammation and bone-related markers in the gum fluid. The main questions it aims to answer are :
- Does the application of PRF or i-PRF improve clinical periodontal healing compared to standard treatment alone?
- Do these applications influence the levels of inflammatory and bone metabolism-related biomarkers in gingival crevicular fluid? Researchers will compare patients receiving PRF or i-PRF in addition to standard periodontal treatment with those receiving standard treatment alone. In addition, the findings obtained from individuals with periodontal disease will be compared with data from periodontally healthy individuals.
Participants will:
- Receive standard periodontal treatment (scaling and root planing)
- Receive PRF or i-PRF depending on their assigned group
- Visit the clinic before treatment and at 2, 4, and 6 weeks after treatment for checkups
Detailed description
his study was designed as a randomized controlled clinical trial to evaluate the adjunctive effects of platelet-rich fibrin (PRF) and injectable platelet-rich fibrin (i-PRF) in individuals with periodontitis undergoing non-surgical periodontal therapy (NSPT).
A total of 56 participants were included in the study, comprising 42 systemically healthy patients diagnosed with periodontitis and 14 systemically and periodontally healthy individuals serving as controls. Periodontitis patients were randomly allocated into three treatment groups using a sealed-envelope method: NSPT alone (scaling and root planing, SRP), NSPT with adjunctive PRF application, and NSPT with adjunctive i-PRF application.
PRF and i-PRF were prepared from autologous venous blood obtained from the participants and were applied locally into periodontal pockets immediately following SRP.
Clinical periodontal parameters were recorded at baseline and at the 2nd, 4th, and 6th weeks following treatment. Gingival crevicular fluid (GCF) samples were collected at baseline and at the 2nd and 6th weeks. The levels of inflammatory cytokines (IL-1β, TNF-α, IL-6) and bone metabolism-related biomarkers (OPG and RANKL) in GCF were quantified using enzyme-linked immunosorbent assay (ELISA).
The findings of this study provided insight into the potential clinical and biochemical benefits of PRF and i-PRF as adjunctive approaches in NSPT and allowed comparison with periodontally healthy conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-surgical periodontal therapy (NSPT) | Active comparator | Procedure: Non-surgical periodontal therapy (NSPT)Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). No adjunctive biomaterial was applied. |
| NSPT + PRF | Experimental | Procedure: Non-surgical periodontal therapy (NSPT), Biological: Platelet-rich fibrin (PRF)Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, platelet-rich fibrin (PRF) was applied into periodontal pockets. |
| NSPT + i-PRF | Experimental | Procedure: Non-surgical periodontal therapy (NSPT), Biological: Injectable platelet-rich fibrin (i-PRF)Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, injectable platelet-rich fibrin (i-PRF) was applied into periodontal pockets. |
| Healthy control | No intervention | –Periodontally and systemically healthy participants were included as controls. No periodontal treatment was performed. Gingival crevicular fluid (GCF) samples were collected, and oral hygiene instructions were provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary consent to participate in the study
- Individuals aged 18 years or older
- Systemically healthy individuals
- Abstaining from the use of any drugs for any purpose
- No periodontal treatment history in the past six months
Key exclusion criteria (8 listed)
- Absence of willingness to engage in the studies
- Individuals under the age of 18
- Existence of any systemic disease influencing periodontal condition and consistent medication usage
- Administration of local or systemic antibiotics within the preceding six months
- Chronicle of periodontal therapy during the past six months
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 |
|---|---|---|
| Non-surgical periodontal therapy (NSPT)Non-surgical periodontal therapy (NSPT) consisted of full-mouth scaling and root planing (SRP), including the removal of supra- and subgingival deposits using ultrasonic devices and hand instruments. | Procedure or surgery | NSPT + PRF, NSPT + i-PRF, Non-surgical periodontal therapy (NSPT) |
| Platelet-rich fibrin (PRF)Platelet-rich fibrin (PRF) was prepared from autologous venous blood by centrifugation at 2700 rpm for 12 minutes, processed into a membrane, adapted to the size of the periodontal pocket, and placed into the periodontal pocket using hand instruments. | Biological | NSPT + PRF |
| Injectable platelet-rich fibrin (i-PRF)Injectable platelet-rich fibrin (i-PRF) was prepared from autologous venous blood by low-speed centrifugation at 700 rpm for 3 minutes and injected into periodontal pockets. | Biological | NSPT + i-PRF |
Primary outcome
Change in probing depth (PD)
Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks
Change in probing depth (PD) measured in millimeters at six sites per tooth using a periodontal probe, comparing baseline values with follow-up measurements.
9 secondary outcomes
Change in clinical attachment level (CAL)
Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks
Change in plaque index (PI)
Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks
Change in gingival index (GI)
Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks
Change in bleeding on probing (BoP)
Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks
Change in gingival crevicular fluid (GCF) IL-1β levels
Time frame: Baseline, 2 weeks, and 6 weeks
Change in gingival crevicular fluid (GCF) TNF-α levels
Time frame: Baseline, 2 weeks, and 6 weeks
Change in gingival crevicular fluid (GCF) IL-6 levels
Time frame: Baseline, 2 weeks, and 6 weeks
Change in gingival crevicular fluid (GCF) OPG levels
Time frame: Baseline, 2 weeks, and 6 weeks
Change in gingival crevicular fluid (GCF) RANKL levels
Time frame: Baseline, 2 weeks, and 6 weeks
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 15 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 Non-surgical periodontal therapy (NSPT), Platelet-rich fibrin (PRF) and Injectable platelet-rich fibrin (i-PRF) in people with Periodontitis, run by Ondokuz Mayıs University 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 6 inclusion and 8 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 15 Apr 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 probing depth (PD) (time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks). 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 15 Apr 2026.