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Completed

NCT Number: NCT06870786

Effect of Vitamin D Deficiency on the Structure of Titanium Platelet-Rich Fibrin

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.

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Key information

Conditions

PRF Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency Vitamin Deficiency

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology, Faculty of Dentistry, Bolu Abant İzzet Baysal University,

Bolu, 14100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D (Cholecalciferol )

Dietary Supplement

Evaluation of T-PRF membrane structures obtained from the blood of patients before and after vitamin D supplementation.

Primary outcomes

  1. 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

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

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

Acronym: T-Prf

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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