Platelet-Rich Fibrin Clinical Trial
Official title:
Evaluation of the Effects of Injectable Platelet-rich Fibrin (i-PRF) Application on Periodontal Clinical and Biochemical Parameters in Gingival Crevicular Fluid (GCF) in Non-surgical Periodontal Treatment
Verified date | February 2023 |
Source | Pamukkale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Injectable platelet-rich fibrin, a platelet concentrate in a liquid formulation, has been developed to provide clinicians with ease of use alone or in combination with various biomaterials. The low-speed centrifugation method provides a significant advantage to the regeneration process with richer platelets, leukocytes, and growth factors. It also contributes to the wound-healing process by increasing vascularization. It is expected that the application of injectable platelet-rich fibrin into the gingival pocket following subgingival curettage in periodontitis patients will positively affect the results of non-surgical periodontal treatment. For this reason, in this study it was aimed to investigate the early effects of injectable PRF applied into the pocket for root surface biomodification following subgingival curettage in periodontal pockets of 6 mm and above, by evaluating both clinical parameters and inflammatory and healing markers in the gingival groove fluid
Status | Completed |
Enrollment | 24 |
Est. completion date | January 15, 2023 |
Est. primary completion date | November 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - patients with stage 3 grade B periodontitis Exclusion Criteria: - patients with systemic disease - pregnant and breastfeeding - acute or chronic infection in the past 6 months - Use of systemic antibiotic therapy in the past 6 months - use of drugs that can affect periodontal health - receiving hormone therapy - smokers - teeth with endodontic lesions - Teeth with class 2 and 3 mobility |
Country | Name | City | State |
---|---|---|---|
Turkey | Gizem Torumtay Cin | Denizli | Deni?zli? |
Lead Sponsor | Collaborator |
---|---|
Pamukkale University |
Turkey,
Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radi — View Citation
Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GCF VEGF levels in test and control groups | measure and compare the improvement of VEGF in test and control groups by using ELISA | Change from Baseline GCF VEGF levels at 3rd and 7th days | |
Primary | GCF TNF-alpha levels in test and control groups | measure and compare the improvement of TNF-alpha in test and control groups by using ELISA | Change from Baseline GCF TNF-alpha levels at 3rd and 7th days | |
Primary | GCF IL-10 levels in test and control groups | measure and compare the improvement of IL-10 in test and control groups by using ELISA | Change from Baseline GCF IL-10 levels at 3rd and 7th days | |
Primary | Plaque index (PI) | measure and compare the improvement of PI in test and control groups using a scale | Change from Baseline PI at 3rd and 7th days | |
Primary | Probing depth (PD) | measure the gingival margin to pocket bottom as mm and compare the improvement of PD in test and control groups | Change from Baseline PD levels at 3rd and 7th days | |
Primary | Gingival index (GI) | measure and compare the improvement of GI in test and control groups using a scale | Change from Baseline GI at 3rd and 7th days | |
Primary | Bleeding on probing (BOP) | Whether there is bleeding when the periodontal pocket is probed and comparing the improvement in test and control groups | Change from Baseline BOP at 3rd and 7th days | |
Primary | Clinical attachment level (CAL) | measure the distance from the cemento-enamel line to the bottom of the pocket and compare the improvement in test and control groups | Change from Baseline CAL at 3rd and 7th days |
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