Clinical Trials Directory

Trials / Completed

CompletedNCT05753631

Effects of i-PRF on Non-surgical Periodontal Treatment

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

Status
Completed
Phase
Study type
Observational
Enrollment
24 (actual)
Sponsor
Pamukkale University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

The study was planned as a randomized controlled split-mouth clinical trial. A split-mouth design was used to better assess how the same host responded to two different treatment modalities. Two quadrants with contralateral deep periodontal pockets in each participant were selected and randomly divided into test and control groups. Test group: Injectable platelet-rich fibrin application into the selected deep periodontal pocket after scaling and root planning (SRP) procedure. Control group: No agent was applied to the periodontal pocket after scaling and root planning. On the first visit, clinical periodontal measurements were taken before the SRP procedure. Plague index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) were used as clinical periodontal parameters. After 1 week, the patients were called again for the SRP procedure. Injectable PRF obtained from the intravenous blood sample taken from the antecubital vein of the patients was injected into the deepened periodontal pocket subgingivally after the SRP procedure in the test group. Clinical periodontal measurements at 1 month and 3 months after SRP were repeated. Gingival crevicular fluid (GCF) samples were taken from selected teeth before the SRP procedure. On the 3rd and 7th day after the SRP, GCF samples were taken again from the same region. GCF vascular endothelial growth factor (VEGF), tumor necrosis factor-alpha (TNF-α), and interleukin (IL)-10 levels were evaluated by using the ELISA method and compared between groups.

Conditions

Interventions

TypeNameDescription
PROCEDUREnon surgical periodontal treatmentscaling and root planning were applied for non-surgical periodontal treatment i-PRF application: Intravenous blood sample taken from the antecubital vein of the patients was collected in a 10 ml tube and centrifuged at 700 rpm for 3 minutes in a PRF centrifuge device. The PRF obtained from the upper liquid layer formed in the tube was injected subgingival into the deepest point of the pocket after SRP treatment. Clinical periodontal measurements: plaque index, gingival index, probing depth, clinical attachment level, bleeding on probing, and gingival recession were calculated. gingival crevicular fluid: Perio papers were placed in the deepest part of the sulcus and left for 30 seconds. After 30 seconds, the paper strips were placed in the periotron device and the volume was calculated.

Timeline

Start date
2022-02-02
Primary completion
2022-11-15
Completion
2023-01-15
First posted
2023-03-03
Last updated
2023-03-03

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05753631. Inclusion in this directory is not an endorsement.