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 (PRFperio)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontitis; Periodontal Disease
• Intervention / Treatment: Procedure: SRP; Biological: SRP+iPRF

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Białystok, Poland, 15-089
    • Department of Integrated Dentistry, Medical University of Białystok

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SRP; In the control group (20 subjects) SRP was performed alone.	Procedure: SRP; SRP (scaling and root planing)
Experimental: SRP+iPRF; The test group consisted of 20 people participants who underwent the SRP procedure and then i-PRF was administered into the pockets.	Biological: SRP+iPRF; SRP (scaling and root planing) with iPRF (injectable platelet-rich fibrin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 6 months after treatment procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 3 months after treatment procedure

Collaborators and Investigators

• Sponsor: Medical University of Bialystok

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: SRP; periodontitis; PRF
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Periodontitis; Inflammation; Periodontal Diseases
• Other Study ID Numbers: UniBial; APK.002.122.2022 (Other Identifier: University of Bialystok)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD cannot be transferred to other people due to GDPR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No