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

NCT06870786 | Completed DMC

• 1 other identifier: AibuIBU
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

PRF; Vitamin D Deficiency; Vitamin Deficiency

Outcome Measures

Primary Outcomes (1)

• microscopic analysis

  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 Outcomes (2)

• 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

Study Arms (2)

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.

Dietary Supplement: Vitamin D (Cholecalciferol )

Vitamin D level is optimal

NO INTERVENTION

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

Interventions

Vitamin D (Cholecalciferol ) DIETARY_SUPPLEMENT

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

with vitamin D deficiency

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

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

Bolu, Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Avitaminosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistan professor

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 11, 2025
• Study Start: January 21, 2021
• Primary Completion: May 15, 2021
• Study Completion: June 2, 2021
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)