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

March 5, 2025 updated by: Esra ATEŞ, Abant Izzet Baysal University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bolu, Turkey, 14100
        • Department of Periodontology, Faculty of Dentistry, Bolu Abant İzzet Baysal University,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: with vitamin D deficiency
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.
Evaluation of T-PRF membrane structures obtained from the blood of patients before and after vitamin D supplementation.
No Intervention: Vitamin D level is optimal
Blood was taken from individuals with optimum vitamin D levels to obtain T-PRF membranes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scanning Electron Microscope (SEM) Examination
Time Frame: From enrollment to the end of treatment at 3 months
In order to visualize the surfaces of the samples, they were coated with 20 nm gold/palladium sputtering and photographs were taken and recorded under different magnifications.
From enrollment to the end of treatment at 3 months
T-PRF Degradation of Membranes
Time Frame: From enrollment to the end of treatment at 3 months
T-PRF membranes weighed was placed in an orbital shaking device in 7.4% PBS solution for 1 week in order to evaluate the degradation rates Degradation amounts were calculated as:% degradation=(initial weight-final weight)/initial weight x 100
From enrollment to the end of treatment at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Actual)

May 15, 2021

Study Completion (Actual)

June 2, 2021

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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