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

Not Applicable

Active, not recruiting

• Conditions: Periodontal Disease; Periodontitis
• Interventions: Procedure: SRP; Biological: SRP+iPRF

• Registration Number: NCT06920849
• Lead Sponsor: Medical University of Bialystok

Brief 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.

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 Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRP	SRP	In the control group (20 subjects) SRP was performed alone.
SRP+iPRF	SRP+iPRF	The test group consisted of 20 people participants who underwent the SRP procedure and then i-PRF was administered into the pockets.

Primary Outcome Measures

Name	Time	Method
Assessment of the influence of injectable platelet-rich fibrin on the clinical parameters in non-surgical treatment of periodontitis.	up to 6 months after treatment procedure	PD (Pocket Depth) from the gingival margin to the bottom of the sulcus, measured in mm

Secondary Outcome Measures

Name	Time	Method
Assessment of the influence of injectable platelet-rich fibrin on the levels of inflammation mediators in the GCF in non-surgical treatment of periodontitis.	up to 3 months after treatment procedure	Inflammation mediators level in GCF will be determined by the immunoenzymatic method ELISA (Enzyme - Linked Immunosorbent Assay) with the use of commercial kits.

Trial Locations

Locations (1)

Department of Integrated Dentistry, Medical University of Białystok; 🇵🇱 Białystok, Poland