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

NCT ID: NCT06920849

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2025-06-30

Brief Summary

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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

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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

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Periodontal Disease Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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SRP

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

Group Type EXPERIMENTAL

SRP

Intervention Type PROCEDURE

SRP (scaling and root planing)

SRP+iPRF

The test group consisted of 20 people participants who underwent the SRP procedure and then i-PRF was administered into the pockets.

Group Type EXPERIMENTAL

SRP+iPRF

Intervention Type BIOLOGICAL

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

Interventions

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SRP+iPRF

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

Intervention Type BIOLOGICAL

SRP

SRP (scaling and root planing)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Bialystok

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Integrated Dentistry, Medical University of BiaƂystok

Bialystok, , Poland

Site Status

Countries

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Poland

Other Identifiers

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APK.002.122.2022

Identifier Type: OTHER

Identifier Source: secondary_id

UniBial

Identifier Type: -

Identifier Source: org_study_id

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