Clinical trial NCT06814418: Injectable Platelet Rich Fibrin in Periodontal Treatment
Official title: The Effect of Injectable Platelet Rich Fibrin (iPRF) in Non-surgical Periodontal Treatment- A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periodontitis
Keywords: Periodontitis
Platelet Rich Fibrin
Non surgical
Porphyromonas gingivalis
Filifactor alocis
Pocket closure
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pocket closure - Percentage of successful treatment outcome
timeFrame: 6 months
measure: Bleeding on Probing (BoP) - Change in percentage
timeFrame: 6 months
measure: Clinical Attachment Loss (CAL)
timeFrame: 6 months
Secondary outcomes:
measure: Microbiological Assessment
timeFrame: 6 months
measure: Patient-reported Outcomes
timeFrame: 1 week
measure: Analgesic Intake
timeFrame: 1 week
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Leonidas Batas, Ass. Professor, DDS, MSc, PhD
role: STUDY_DIRECTOR
affiliation: Aristotle University Of Thessaloniki
name: Sofia Zarenti, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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