Injectable Platelet Rich Fibrin in Periodontal Treatment

Not Applicable

Active, not recruiting

• Conditions: Periodontitis

• Registration Number: NCT06814418
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-15
• Study First Submitted: 2024-11-27
• Status Verified: 2025-01
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pocket closure - Percentage of successful treatment outcome	6 months	Pocket closure : clinical Periodontal Marker: probing pocket depth (PPD) ≤4 mm and absence of bleeding on probing (BOP). (Periodontal probe UNC15, Hu-Friedy, Rotterdam, the Netherlands)
Bleeding on Probing (BoP) - Change in percentage	6 months	Clinical Periodontal Marker: Bleeding after slight pressure by a standardized (dimensions and shape) periodontal probe with a controlled (∼0.25 N) force to the apical end of the sulcus (Periodontal probe UNC15, Hu-Friedy, Rotterdam, the Netherlands)
Clinical Attachment Loss (CAL)	6 months	Clinical Periodontal Marker: The distance in mm from the CEJ to the gingival margin (Periodontal probe UNC15, Hu-Friedy, Rotterdam, the Netherlands)

Secondary Outcome Measures

Name	Time	Method
Microbiological Assessment	6 months	Presence and quantification of bacteria: -Porphyromonas gingivalis (Pg), Filifactor Alocis (F.Alocis)- will be examined by quantitative polymerase chain reaction (qPCR).; Reduction or absence of these specific bacteria leads to reduction of inflammation and results in non-progression of periodontal disease (reduction of probing depth (PPD), gain of clinical attachment level (CAL), less bleeding on probing (BOP) and pocket closure )
Patient-reported Outcomes	1 week	Patient-reported outcomes will be assessed using the McGill Pain Questionnaire-2 (SF-MPQ-2) short form.; It includes 22 descriptors, each descriptor is rated on a 0-10 numerical scale, where 0 = no pain and 10 = worst possible pain, reflecting the severity of each pain characteristic over the past week.
Analgesic Intake	1 week	The number and type of analgesics taken by the patient will be recorded for each individual day during the week following the treatment

Trial Locations

Locations (1)

Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece