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Active, Not Recruiting

NCT Number: NCT06920849

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Periodontal Disease Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Integrated Dentistry, Medical University of Białystok

Bialystok, 15-089, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SRP+iPRF

Biological

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

SRP

Procedure

SRP (scaling and root planing)

Primary outcomes

  1. 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

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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Acronym: PRFperio

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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