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Clinical Trials/NCT05753631
NCT05753631
Completed
N/A

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

Pamukkale University1 site in 1 country24 target enrollmentFebruary 2, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Platelet-Rich Fibrin
Sponsor
Pamukkale University
Enrollment
24
Locations
1
Primary Endpoint
GCF VEGF levels in test and control groups
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2, 2022
End Date
January 15, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

AYSAN LEKTEMUR ALPAN

Associate Profesor

Pamukkale University

Eligibility Criteria

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
  • teeth with endodontic lesions
  • Teeth with class 2 and 3 mobility

Outcomes

Primary Outcomes

GCF VEGF levels in test and control groups

Time Frame: Change from Baseline GCF VEGF levels at 3rd and 7th days

measure and compare the improvement of VEGF in test and control groups by using ELISA

Plaque index (PI)

Time Frame: Change from Baseline PI at 3rd and 7th days

measure and compare the improvement of PI in test and control groups using a scale

GCF IL-10 levels in test and control groups

Time Frame: Change from Baseline GCF IL-10 levels at 3rd and 7th days

measure and compare the improvement of IL-10 in test and control groups by using ELISA

Clinical attachment level (CAL)

Time Frame: Change from Baseline CAL at 3rd and 7th days

measure the distance from the cemento-enamel line to the bottom of the pocket and compare the improvement in test and control groups

GCF TNF-alpha levels in test and control groups

Time Frame: Change from Baseline GCF TNF-alpha levels at 3rd and 7th days

measure and compare the improvement of TNF-alpha in test and control groups by using ELISA

Probing depth (PD)

Time Frame: Change from Baseline PD levels at 3rd and 7th days

measure the gingival margin to pocket bottom as mm and compare the improvement of PD in test and control groups

Gingival index (GI)

Time Frame: Change from Baseline GI at 3rd and 7th days

measure and compare the improvement of GI in test and control groups using a scale

Bleeding on probing (BOP)

Time Frame: Change from Baseline BOP at 3rd and 7th days

Whether there is bleeding when the periodontal pocket is probed and comparing the improvement in test and control groups

Study Sites (1)

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