Periodontitis
Conditions
Keywords
Periodontitis, Platelet Rich Fibrin, Non surgical, Porphyromonas gingivalis, Filifactor alocis, Pocket closure
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.
Interventions
PROCEDURENon-surgical periodontal treatment
Step I and II of periodontal treatment.
PROCEDUREInjectable Platelet Rich Fibrin (I-PRF)
Infusion of I-PRF in sited with PPD≥5mm.
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Greece
Outcome results
None listed