Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT06814418
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-07
First Post:
2024-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Injectable Platelet Rich Fibrin in Periodontal Treatment
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Study Overview
Official Title:
The Effect of Injectable Platelet Rich Fibrin (iPRF) in Non-surgical Periodontal Treatment- A Randomized Controlled Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
I-PRF
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: