Periodontitis Stage IIINCT07029035
Evaluation of Repeated Injectable PRF Following SRP in Patients With Periodontitis
A study testing İnjectable platelet-rich fibrin and Sterile saline (0.9%) in people with Periodontitis Stage III, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if a treatment called injectable platelet-rich fibrin (i-PRF) helps improve gum health in people with a type of gum disease called Stage 3 Grade B periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis Stage III
- What is being tested?
- İnjectable platelet-rich fibrin and Sterile saline (0.9%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 May 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with Stage 3 Grade B periodontitis
- Being between the ages of 18-65
Who cannot join
- Smoking
- Having a systemic disease
- Taking any medication
- Being pregnant or breastfeeding
- Having received chemotherapy, radiotherapy or immunosuppressant treatments
- Having received periodontal treatment in the last 6 months
- Having used antibiotics in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi Gulhane Dis Hekimligi Fakultesi
Ankara
About this study
Official title: Evaluation of the Clinical and Biochemical Efficacy of Repeated Injectable Platelet-Rich Fibrin Application Following Scaling and Root Planing in Patients With Periodontitis
The goal of this clinical trial is to learn if a treatment called injectable platelet-rich fibrin (i-PRF) helps improve gum health in people with a type of gum disease called Stage 3 Grade B periodontitis.
The main questions this study aims to answer are:
Read more
Does i-PRF help reduce gum inflammation and support healing? Are there changes in certain biological markers after using i-PRF? Researchers will compare two sides of the mouth. One side will receive i-PRF, and the other will be treated with salt water (saline) as a comparison.
Participants will:
Have a dental cleaning called scaling and root planing (SRP) Get i-PRF injected into deep gum pockets on one side of the mouth Have salt water placed in the other side's gum pockets Give gum fluid samples and have gum measurements taken at several visits (including 3 months later) Provide a small blood sample to prepare the i-PRF Researchers will collect and study gum fluid and look at markers related to healing and inflammation. The study will help find out if i-PRF is useful as a new treatment option for gum disease.
Read the detailed description
A total of 20 patients diagnosed with Stage 3 Grade B Periodontitis based on clinical and radiographic findings will be included in this study at the Department of Periodontology, Faculty of Dentistry, Gülhane University. Eligible participants will be systemically healthy, non-smokers, not pregnant or breastfeeding, not on any medications, and must not have received any periodontal treatment or antibiotics within the past six months.
All participants will be informed about the study in detail, and written and verbal informed consent will be obtained from those who voluntarily agree to participate.
The study will be designed as a randomized controlled split-mouth clinical trial, in which the periodontal pockets in one half of the mouth will serve as the test site, and those in the other half will serve as the control site. Allocation of test and control sides will be determined by coin toss. Baseline and 3-month clinical periodontal parameters - including Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL) will be recorded using a Williams periodontal probe.
For biochemical analysis, gingival crevicular fluid (GCF) samples will be collected from the deepest periodontal pockets at the test and control sites at four time points: baseline, 7 days after the first application of injectable platelet-rich fibrin (i-PRF), 7 days after the second application, and at 3 months. GCF collection will be performed using Periopaper strips after isolating the area with cotton rolls and gently removing supragingival plaque. Strips will be inserted into the pocket until resistance is felt, held in place for 15 seconds, and then analyzed for volume using a Periotron device. Samples will then be stored in Eppendorf tubes at -80°C until biochemical analysis. Levels of Platelet Factor-4 (PF-4), Myeloperoxidase (MPO), Transforming Growth Factor Beta (TGF-β), and Platelet-Derived Growth Factor (PDGF) in GCF will be analyzed using ELISA.
Following baseline measurements and GCF sampling, scaling and root planing (SRP) will be performed in two sessions, spaced one week apart, using standard ultrasonic and hand instruments (curettes and Gracey curettes).Venous blood samples (15 ml) will be drawn from the antecubital vein using sterile syringes and transferred into two plain tubes. The samples will be centrifuged at 1000 rpm for 3 minutes. The injectable platelet-rich fibrin (i-PRF) from the upper layer will be collected using a 5 ml syringe and administered into all deep periodontal pockets (≥4 mm) in the test quadrant. The application will be followed by gentle digital compression with a gauze sponge for 1 minute to allow polymerization and retention of the material.
In the control quadrant, deep pockets will be irrigated with sterile saline solution and similar digital compression will be applied to ensure blinding of the participants to the allocation. On the third week, the procedure will be repeated: i-PRF will be reapplied to the test sites, and saline irrigation will be repeated for the control sites. At the 3-month follow-up, all clinical indices will be reassessed, and last GCF samples will be collected.
Statistical Analysis:
All data will be analyzed using SPSS for Windows, Version 26.0 (SPSS Inc., USA). Descriptive statistics will be presented as mean ± standard deviation for continuous variables. The Shapiro-Wilk test will be used to assess the normality of data distribution. Differences between test and control sites and between time points will be analyzed using the paired samples t-test or Wilcoxon signed-rank test, depending on data distribution. A p-value of <0.05 will be considered statistically significant.
A power analysis, based on a similar previous study, indicated that including 20 test and 20 control samples (a total of 40 sites) would provide 98% statistical power.
An application will be submitted to the Scientific Research Projects Coordination Unit (BAP) to support the study with required materials and kits.
- Conditions
- Periodontitis Stage III
- Being tested
- İnjectable platelet-rich fibrin, Sterile saline (0.9%)
- Keywords
- Tgf-β, Prf, Pf 4, Periodontitis, Pdgf, Split mouth, Mpo, İ-prf
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İnjectable platelet-rich fibrinBiological
Repeated application of I-PRF to the periodontal pockets in the test sites was performed twice: once immediately following scaling and root planing (SRP), and once at the third week.
Sterile saline (0.9%)Other
Control sites received a sham intervention consisting of sterile saline solution irrigation into the periodontal pockets, to mimic the procedural aspects of PRF placement without delivering any biologically active material.
| Study group | Role | What they receive |
|---|---|---|
| Test Site | Experimental | Repeated application of İ-PRF to periodontal pockets in the test sites. Receives: Biological: İnjectable platelet-rich fibrin |
| Control Site | Sham comparator | Control sites received a sham intervention consisting of sterile saline solution irrigation into the periodontal pockets, to mimic the procedural aspects of PRF placement without delivering any biologically active material. Receives: Other: Sterile saline (0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in GCF levels of TGF-β and PDGF at multiple time points.
Biochemical markers will be analyzed at baseline, 2 weeks, 4 weeks, and 3 months. The biochemical data will be correlated with clinical periodontal parameters to assess the relationship between molecular changes and clinical outcomes, thereby providing a comprehensive evaluation of treatment efficacy.
Measured: From baseline to third month
Changes in clinical periodontal parameters, including Probing Pocket Depth and Clinical Attachment Level, will be evaluated at baseline and at the third month.
Clinical data will be evaluated at baseline and at the third month.
Measured: From baseline to third month
Secondary outcomes (2)
Changes in GCF levels of PF 4 and MPO at multiple time points.
Clinical data will be evaluated at baseline and at the third month, while biochemical markers will be analyzed at baseline, 2 weeks, 4 weeks, and 3 months. The biochemical data will be correlated with clinical periodontal parameters to assess the relationship between molecular changes and clinical outcomes, thereby providing a comprehensive evaluation of treatment efficacy.
Measured: From baseline to third month
Changes in clinical periodontal parameters, including Plaque Index, Gingival Index, and Bleeding on Probing evaluated at baseline and at the third month.
Clinical data will be evaluated at baseline and at the third month.
Measured: From baseline to third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Dec 2023
- Primary completion1 Dec 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontitis Stage IIIStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Crossover
- Model description
- This study utilized a split-mouth, within-subject design rather than a classical crossover or parallel group design. Each subject received both the intervention (PRF) and control (no PRF) on different sites of the oral cavity.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences University-Scientific Research Projects Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029035
- Sponsor's protocol ID
- 2023/254
- Status last verified
- Oct 2023
- First submitted
- 28 May 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ulu Emir B, Ozcan E, Avci E. Clinical and Biochemical Effects of Repeated Injectable Platelet-Rich Fibrin Application in Periodontitis Treatment: A Randomized Controlled Clinical Trial. Int J Dent Hyg. 2026 Sep 14. doi: 10.1111/idh.70162. Online ahead of print.
PubMed 42736613
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical and Biochemical Efficacy of Repeated Injectable Platelet-Rich Fibrin Application Following Scaling and Root Planing in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT07029035
- Acronym / sponsor ID
- 2023/254
- Conditions
- Periodontitis Stage III
- Keywords
- Tgf-β, Prf, Pf 4, Periodontitis, Pdgf, Split mouth, Mpo, İ-prf
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Health Sciences University-Scientific Research Projects Unit
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 19 Jun 2025 (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 a treatment called injectable platelet-rich fibrin (i-PRF) helps improve gum health in people with a type of gum disease called Stage 3 Grade B periodontitis.
The main questions this study aims to answer are:
Does i-PRF help reduce gum inflammation and support healing? Are there changes in certain biological markers after using i-PRF? Researchers will compare two sides of the mouth. One side will receive i-PRF, and the other will be treated with salt water (saline) as a comparison.
Participants will:
Have a dental cleaning called scaling and root planing (SRP) Get i-PRF injected into deep gum pockets on one side of the mouth Have salt water placed in the other side's gum pockets Give gum fluid samples and have gum measurements taken at several visits (including 3 months later) Provide a small blood sample to prepare the i-PRF Researchers will collect and study gum fluid and look at markers related to healing and inflammation. The study will help find out if i-PRF is useful as a new treatment option for gum disease.
Detailed description
A total of 20 patients diagnosed with Stage 3 Grade B Periodontitis based on clinical and radiographic findings will be included in this study at the Department of Periodontology, Faculty of Dentistry, Gülhane University. Eligible participants will be systemically healthy, non-smokers, not pregnant or breastfeeding, not on any medications, and must not have received any periodontal treatment or antibiotics within the past six months.
All participants will be informed about the study in detail, and written and verbal informed consent will be obtained from those who voluntarily agree to participate.
The study will be designed as a randomized controlled split-mouth clinical trial, in which the periodontal pockets in one half of the mouth will serve as the test site, and those in the other half will serve as the control site. Allocation of test and control sides will be determined by coin toss. Baseline and 3-month clinical periodontal parameters - including Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL) will be recorded using a Williams periodontal probe.
For biochemical analysis, gingival crevicular fluid (GCF) samples will be collected from the deepest periodontal pockets at the test and control sites at four time points: baseline, 7 days after the first application of injectable platelet-rich fibrin (i-PRF), 7 days after the second application, and at 3 months. GCF collection will be performed using Periopaper strips after isolating the area with cotton rolls and gently removing supragingival plaque. Strips will be inserted into the pocket until resistance is felt, held in place for 15 seconds, and then analyzed for volume using a Periotron device. Samples will then be stored in Eppendorf tubes at -80°C until biochemical analysis. Levels of Platelet Factor-4 (PF-4), Myeloperoxidase (MPO), Transforming Growth Factor Beta (TGF-β), and Platelet-Derived Growth Factor (PDGF) in GCF will be analyzed using ELISA.
Following baseline measurements and GCF sampling, scaling and root planing (SRP) will be performed in two sessions, spaced one week apart, using standard ultrasonic and hand instruments (curettes and Gracey curettes).Venous blood samples (15 ml) will be drawn from the antecubital vein using sterile syringes and transferred into two plain tubes. The samples will be centrifuged at 1000 rpm for 3 minutes. The injectable platelet-rich fibrin (i-PRF) from the upper layer will be collected using a 5 ml syringe and administered into all deep periodontal pockets (≥4 mm) in the test quadrant. The application will be followed by gentle digital compression with a gauze sponge for 1 minute to allow polymerization and retention of the material.
In the control quadrant, deep pockets will be irrigated with sterile saline solution and similar digital compression will be applied to ensure blinding of the participants to the allocation. On the third week, the procedure will be repeated: i-PRF will be reapplied to the test sites, and saline irrigation will be repeated for the control sites. At the 3-month follow-up, all clinical indices will be reassessed, and last GCF samples will be collected.
Statistical Analysis:
All data will be analyzed using SPSS for Windows, Version 26.0 (SPSS Inc., USA). Descriptive statistics will be presented as mean ± standard deviation for continuous variables. The Shapiro-Wilk test will be used to assess the normality of data distribution. Differences between test and control sites and between time points will be analyzed using the paired samples t-test or Wilcoxon signed-rank test, depending on data distribution. A p-value of <0.05 will be considered statistically significant.
A power analysis, based on a similar previous study, indicated that including 20 test and 20 control samples (a total of 40 sites) would provide 98% statistical power.
An application will be submitted to the Scientific Research Projects Coordination Unit (BAP) to support the study with required materials and kits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study utilized a split-mouth, within-subject design rather than a classical crossover or parallel group design. Each subject received both the intervention (PRF) and control (no PRF) on different sites of the oral cavity.
| Arm | Type | Receives |
|---|---|---|
| Test Site | Experimental | Biological: İnjectable platelet-rich fibrinRepeated application of İ-PRF to periodontal pockets in the test sites. |
| Control Site | Sham comparator | Other: Sterile saline (0.9%)Control sites received a sham intervention consisting of sterile saline solution irrigation into the periodontal pockets, to mimic the procedural aspects of PRF placement without delivering any biologically active material. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being diagnosed with Stage 3 Grade B periodontitis
- Being between the ages of 18-65
Key exclusion criteria (7 listed)
- Smoking
- Having a systemic disease
- Taking any medication
- Being pregnant or breastfeeding
- Having received chemotherapy, radiotherapy or immunosuppressant treatments
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 |
|---|---|---|
| İnjectable platelet-rich fibrinRepeated application of I-PRF to the periodontal pockets in the test sites was performed twice: once immediately following scaling and root planing (SRP), and once at the third week. | Biological | Test Site |
| Sterile saline (0.9%)Control sites received a sham intervention consisting of sterile saline solution irrigation into the periodontal pockets, to mimic the procedural aspects of PRF placement without delivering any biologically active material. | Other | Control Site |
Primary outcome
Changes in GCF levels of TGF-β and PDGF at multiple time points.
Time frame: From baseline to third month
Biochemical markers will be analyzed at baseline, 2 weeks, 4 weeks, and 3 months. The biochemical data will be correlated with clinical periodontal parameters to assess the relationship between molecular changes and clinical outcomes, thereby providing a comprehensive evaluation of treatment efficacy.
Changes in clinical periodontal parameters, including Probing Pocket Depth and Clinical Attachment Level, will be evaluated at baseline and at the third month.
Time frame: From baseline to third month
Clinical data will be evaluated at baseline and at the third month.
2 secondary outcomes
Changes in GCF levels of PF 4 and MPO at multiple time points.
Time frame: From baseline to third month
Changes in clinical periodontal parameters, including Plaque Index, Gingival Index, and Bleeding on Probing evaluated at baseline and at the third month.
Time frame: From baseline to third month
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 31 Dec 2025.
- Derived from this study: PubMed 42736613Ulu Emir B, Ozcan E, Avci E. Clinical and Biochemical Effects of Repeated Injectable Platelet-Rich Fibrin Application in Periodontitis Treatment: A Randomized Controlled Clinical Trial. Int J Dent Hyg. 2026 Sep 14. doi: 10.1111/idh.70162. Online ahead of print.
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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 İnjectable platelet-rich fibrin and Sterile saline (0.9%) in people with Periodontitis Stage III, run by Saglik Bilimleri Universitesi 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 2 inclusion and 7 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 31 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
Changes in GCF levels of TGF-β and PDGF at multiple time points. (time frame: From baseline to third month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07029035, which also lists 1 linked publication.
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 31 Dec 2025.