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

NCT06920849 | Active Not Recruiting

• 2 other identifiers: UniBialAPK.002.122.2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease; Periodontitis

Keywords

periodontitis; SRP; PRF

Outcome Measures

Primary Outcomes (1)

• 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 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.

  up to 3 months after treatment procedure

Study Arms (2)

SRP

EXPERIMENTAL

In the control group (20 subjects) SRP was performed alone.

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.

Biological: SRP+iPRF

Interventions

SRP+iPRF BIOLOGICAL

SRP (scaling and root planing) with iPRF (injectable platelet-rich fibrin)

SRP+iPRF

SRP PROCEDURE

SRP (scaling and root planing)

SRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Department of Integrated Dentistry, Medical University of Białystok

Bialystok, 15-089, Poland

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 10, 2025
• Study Start: April 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)