Injectable Platelet Rich Fibrin in Periodontal Treatment (I-PRF)

Aristotle University Of Thessaloniki

Status: Active, not recruiting

Conditions: Periodontitis

Treatments: Procedure: Injectable Platelet Rich Fibrin (I-PRF); Procedure: Non-surgical periodontal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06814418

234/21-03-2023

Details and patient eligibility

About

The aim of this randomized controlled parallel clinical trial is to investigate the efficacy of injectable Platelet Rich Fibrin (iPRF) as an adjunctive to non-surgical periodontal therapy (STEP 1 & 2 of periodontal treatment).

Thirty-two (32) patients diagnosed with stage III periodontitis will be randomly assigned to two study groups. Participants will receive non-surgical periodontal treatment only (control group) or non-surgical periodontal treatment with iPRF (test group). Patients will receive step 1 and 2 of periodontal treatment. Step 2 of periodontal treatment will be completed in one visit. Test group also will receive immediately after the subgingival instrumentation iPRF at the sites with PPD≥5mm.

Subgingival plaque will be collected with paper points at different time points- baseline: before treatment, 3 and 6 months after treatment.

The presence and quantification of bacteria: -Porphyromonas gingivalis (Pg), Filifactor Alocis (F.Alocis)- will be examined with quantitative polymerase chain reaction (q PCR). Clinical parameters, including bleeding on probing (BOP), probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (REC) will be recorded at baseline, 3 and 6 months after treatment.

Patient satisfaction will be assessed through questionnaires regarding quality of life, pain perception and the use of analgesics. The questionnaires will be completed one week after subgingival instrumentation.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages Eligible for Study: >18 years old (Adults)
• Diagnosed Periodontitis Stage III
• Presence of ≥ 15 teeth
• Signed written consent form by patient

Exclusion criteria

• At least one edentulous jaw
• Need for chemoprophylaxis before treatment
• Periodontal treatment the last 6 months
• Antibiotic treatment the last 6 months
• Immunomodulatory diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis), for which patients do not take medication
• HbA1c> 7.0% in patients with diabetes
• Pregnancy/ Lactation
• Medications or undergoing treatment which may affect mucosal healing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Test

Experimental group

Description:

Non-surgical periodontal treatment + injectable Platelet Rich Fibrin

Treatment:

Procedure: Non-surgical periodontal treatment

Procedure: Injectable Platelet Rich Fibrin (I-PRF)

Control

Active Comparator group

Description:

Non-surgical periodontal treatment

Treatment:

Procedure: Non-surgical periodontal treatment