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Clinical Trials/NCT06870786
NCT06870786CompletedNot Applicable

Effect of Vitamin D Deficiency on the Structure of Titanium Platelet-Rich Fibrin(T-Prf)

Abant Izzet Baysal University1 site in 1 country24 target enrollmentStarted: January 21, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
microscopic analysis

Study Overview

Brief Summary

ABSTRACT The aim of the study was to compare the macroscopic properties, chemical degradation levels, and fibrin network structures of T-PRF membranes obtained from systemically healthy individuals with optimal vitamin D levels, with vitamin D-deficient individuals who reached optimal levels after three months of vitamin D supplementation.

A total of 48 participants, 24 with vitamin D deficiency and 24 with optimal vitamin D levels, were included in the study. The macroscopic properties (weight, width, length, density), chemical degradation levels and fibrin network structures of the obtained T-PRF membranes were evaluated using scanning electron microscopy (SEM) and light microscopy.

Detailed Description

Blood samples taken from individuals with the help of a 20 ml syringe were immediately transferred to 2 10 ml titanium tubes and placed opposite each other to ensure balance in the tabletop centrifuge device in order to be properly separated in the centrifuge process. To obtain T-PRF, it was centrifuged in the IntraSpin™ device at 2700 rpm centrifugal force for 12 minutes.

After centrifugation, the fibrin in the middle of the 3 layers formed in the titanium tube was held and pulled with the help of a press. Then, the red layer in the lower layer, where erythrocytes were dense, was separated from the fibrin layer with the help of scissors and the membrane was obtained by pressing for 2 minutes using the own weight of the PRF box.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Individuals aged 20-55
  • •Being systemically healthy
  • •Not using any medication regularly
  • •Not taking additional vitamin D from outside
  • •Patients who met the conditions of not having used antibiotics for the last three months were included in the study.

Exclusion Criteria

  • •People who use cigarettes (tobacco) and alcohol
  • •Those with platelet function and clotting disorders
  • •Those who are pregnant or breastfeeding
  • •Those who use medications that affect the natural clotting process
  • •Those with a history of infection in the last three months
  • •Those receiving immunosuppressive therapy
  • •Those who do not consent to volunteer

Arms & Interventions

with vitamin D deficiency

Experimental

To obtain T-PRF membranes, blood was taken from people diagnosed with vitamin D deficiency. After 3 months, blood was taken from individuals taking vitamin D again to obtain T-PRF membranes.

Intervention: Vitamin D (Cholecalciferol ) (Dietary Supplement)

Vitamin D level is optimal

No Intervention

Blood was taken from individuals with optimum vitamin D levels to obtain T-PRF membranes

Outcomes

Primary Outcomes

microscopic analysis

Time Frame: From enrollment to the end of treatment at 3 months

T-PRF membranes were examined histologically using the cell block cytology method. Membranes were transferred to cassettes and fixed in formalin solution for 24 hours. At the end of 24 hours, the cassettes were subjected to dehydration with various concentrations of formalin, alcohol and xylene. The tissue was embedded in Leucher blocks using paraffin so that it could be easily cut and examined. 3 µm thick sections were taken from the embedded blocks using a microtome. Paraffin in the blocks was removed and the tissue was stained with hematoxylin-eosin L-PRF clot was analyzed microscopically on hematoxylin-eosin stained slides using the blood element adhesion index score 0: absence of fibrin network score 1: sparsely dispersed fibrin network score 2: thin fibrin network poorly interlocking score 3: dense fibrin network abundantly interconnected

Secondary Outcomes

  • Scanning Electron Microscope (SEM) Examination(From enrollment to the end of treatment at 3 months)
  • T-PRF Degradation of Membranes(From enrollment to the end of treatment at 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Esra ATEŞ

Assistan professor

Abant Izzet Baysal University

Study Sites (1)

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