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NCT Number: NCT06814418

Injectable Platelet Rich Fibrin in Periodontal Treatment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non-surgical periodontal treatment

Procedure

Step I and II of periodontal treatment.

Injectable Platelet Rich Fibrin (I-PRF)

Procedure

Infusion of I-PRF in sited with PPD≥5mm.

Primary outcomes

  1. Pocket closure - Percentage of successful treatment outcome

    Time frame: 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)

  2. Bleeding on Probing (BoP) - Change in percentage

    Time frame: 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)

  3. Clinical Attachment Loss (CAL)

    Time frame: 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 outcomes

  1. Microbiological Assessment

    Time frame: 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 )

  2. Patient-reported Outcomes

    Time frame: 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.

  3. Analgesic Intake

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

The Effect of Injectable Platelet Rich Fibrin (iPRF) in Non-surgical Periodontal Treatment- A Randomized Controlled Clinical Trial

Acronym: I-PRF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Feb 7, 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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