Periodontal DiseasePRFperioNCT06920849
Evaluation of the Influence of PRF (Platelet-rich Fibrin) on the Clinical Parameters and the Concentration of Selected Inflammation Mediators in GCF (Gingival Crevice Fluid) of Patients With Periodontitis
A study testing SRP+iPRF and SRP in people with Periodontal Disease and Periodontitis, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
Assessment of the influence of injectable platelet-rich fibrin (i-PRF) on the clinical parameters and the inflammation mediators levels in the gingival crevicular fluid (GCF) in patients with periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Disease, Periodontitis
- What is being tested?
- SRP+iPRF and SRP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical and radiological features of periodontitis in stage II, III or IV
- presence of at least 4 teeth and at least 2 pockets (localized not on the same tooth) with a depth of at least 5 mm in each quadrant
Who cannot join
- periodontal treatment within 3 months prior to the study;
- antibiotic therapy within 3 months prior to the study;
- smoking; presence of systemic diseases affecting periodontal healing, i.e.: immunosuppressive diseases, diabetes, osteoporosis, AIDS, hypertension treated with calcium channel blockers;
- use of steroids or other immunosuppressive drugs;
- coagulation disorders and use of drugs affecting its mechanisms;
- pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Integrated Dentistry, Medical University of Białystok
Bialystok, 15-089
About this study
Assessment of the influence of injectable platelet-rich fibrin (i-PRF) on the clinical parameters and the inflammation mediators levels in the gingival crevicular fluid (GCF) in patients with periodontitis.
Read the detailed description
Forty subjects diagnosed with periodontitis were randomly divided into two groups. In the test group, SRP was performed with the subsequent application of iPRF into periodontal pockets, while in the control group SRP was performed alone. Clinical examination was performed before and 1, 3 and 6 months after treatment. For inflammation mediators levels determination in GCF samples ELISA method will be used.
- Conditions
- Periodontal Disease, Periodontitis
- Being tested
- SRP+iPRF, SRP
- Keywords
- periodontitis, SRP, PRF
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP+iPRFBiological
SRP (scaling and root planing) with iPRF (injectable platelet-rich fibrin)
SRPProcedure or surgery
SRP (scaling and root planing)
| Study group | Role | What they receive |
|---|---|---|
| SRP | Experimental | In the control group (20 subjects) SRP was performed alone. Receives: Procedure: SRP |
| SRP+iPRF | Experimental | The test group consisted of 20 people participants who underwent the SRP procedure and then i-PRF was administered into the pockets. Receives: Biological: SRP+iPRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the influence of injectable platelet-rich fibrin on the clinical parameters in non-surgical treatment of periodontitis.
PD (Pocket Depth) from the gingival margin to the bottom of the sulcus, measured in mm
Measured: up to 6 months after treatment procedure
Secondary outcomes (1)
Assessment of the influence of injectable platelet-rich fibrin on the levels of inflammation mediators in the GCF in non-surgical treatment of periodontitis.
Inflammation mediators level in GCF will be determined by the immunoenzymatic method ELISA (Enzyme - Linked Immunosorbent Assay) with the use of commercial kits.
Measured: up to 3 months after treatment procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Apr 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study group consisted of 20 people participants who underwent the SRP procedure (scaling and root planing) and then i-PRF was administered into the pockets. In the control group also consisting of 20 people only the SRP procedure was performed. The therapeutic procedure was performed under local anesthesia (Septanest 200, Septodont, Paris, France), using an ultrasonic device (EMS Piezon, Tip PS, EMS, Nyon, Switzerland) and hand instruments (Gracey currettes (SMS), Hu-Friedy, Chicago, IL, USA) by one operator. In the test group, i-PRF was prepared using a dedicated device (PRF Duo Quattro Centrifuge, Choukroun Pro-cess For PRF, Nice, France). After the SRP procedure, allocation was performed according to a randomization table prepared by a statistician, and i-PRF was administered into the pockets by one, trained operator.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920849
- Sponsor's protocol ID
- UniBial
- Other IDs
- APK.002.122.2022
- Acronym
- PRFperio
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD cannot be transferred to other people due to GDPR
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of PRF (Platelet-rich Fibrin) on the Clinical Parameters and the Concentration of Selected Inflammation Mediators in GCF (Gingival Crevice Fluid) of Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT06920849
- Acronym / sponsor ID
- PRFperio / UniBial
- Conditions
- Periodontal Disease, Periodontitis
- Keywords
- periodontitis, SRP, PRF
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 Apr 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.
Assessment of the influence of injectable platelet-rich fibrin (i-PRF) on the clinical parameters and the inflammation mediators levels in the gingival crevicular fluid (GCF) in patients with periodontitis.
Detailed description
Forty subjects diagnosed with periodontitis were randomly divided into two groups. In the test group, SRP was performed with the subsequent application of iPRF into periodontal pockets, while in the control group SRP was performed alone. Clinical examination was performed before and 1, 3 and 6 months after treatment. For inflammation mediators levels determination in GCF samples ELISA method will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study group consisted of 20 people participants who underwent the SRP procedure (scaling and root planing) and then i-PRF was administered into the pockets. In the control group also consisting of 20 people only the SRP procedure was performed. The therapeutic procedure was performed under local anesthesia (Septanest 200, Septodont, Paris, France), using an ultrasonic device (EMS Piezon, Tip PS, EMS, Nyon, Switzerland) and hand instruments (Gracey currettes (SMS), Hu-Friedy, Chicago, IL, USA) by one operator. In the test group, i-PRF was prepared using a dedicated device (PRF Duo Quattro Centrifuge, Choukroun Pro-cess For PRF, Nice, France). After the SRP procedure, allocation was performed according to a randomization table prepared by a statistician, and i-PRF was administered into the pockets by one, trained operator.
| Arm | Type | Receives |
|---|---|---|
| SRP | Experimental | Procedure: SRPIn the control group (20 subjects) SRP was performed alone. |
| SRP+iPRF | Experimental | Biological: SRP+iPRFThe test group consisted of 20 people participants who underwent the SRP procedure and then i-PRF was administered into the pockets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical and radiological features of periodontitis in stage II, III or IV
- presence of at least 4 teeth and at least 2 pockets (localized not on the same tooth) with a depth of at least 5 mm in each quadrant
Key exclusion criteria (6 listed)
- periodontal treatment within 3 months prior to the study;
- antibiotic therapy within 3 months prior to the study;
- smoking; presence of systemic diseases affecting periodontal healing, i.e.: immunosuppressive diseases, diabetes, osteoporosis, AIDS, hypertension treated with calcium channel blockers;
- use of steroids or other immunosuppressive drugs;
- coagulation disorders and use of drugs affecting its mechanisms;
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 |
|---|---|---|
| SRP+iPRFSRP (scaling and root planing) with iPRF (injectable platelet-rich fibrin) | Biological | SRP+iPRF |
| SRPSRP (scaling and root planing) | Procedure or surgery | SRP |
Primary outcome
Assessment of the influence of injectable platelet-rich fibrin on the clinical parameters in non-surgical treatment of periodontitis.
Time frame: up to 6 months after treatment procedure
PD (Pocket Depth) from the gingival margin to the bottom of the sulcus, measured in mm
1 secondary outcome
Assessment of the influence of injectable platelet-rich fibrin on the levels of inflammation mediators in the GCF in non-surgical treatment of periodontitis.
Time frame: up to 3 months after treatment procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No. IPD cannot be transferred to other people due to GDPR
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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 SRP+iPRF and SRP in people with Periodontal Disease and Periodontitis, run by Medical University of Bialystok at 1 site in Poland.
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 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: under way, not looking for participants, as of the sponsor's last update on 10 Apr 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Assessment of the influence of injectable platelet-rich fibrin on the clinical parameters in non-surgical treatment of periodontitis. (time frame: up to 6 months after treatment procedure). 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 10 Apr 2025.