- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06870786
Effect of Vitamin D Deficiency on the Structure of Titanium Platelet-Rich Fibrin (T-Prf)
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bolu, Turkey, 14100
- Department of Periodontology, Faculty of Dentistry, Bolu Abant İzzet Baysal University,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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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.
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Evaluation of T-PRF membrane structures obtained from the blood of patients before and after vitamin D supplementation.
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No Intervention: Vitamin D level is optimal
Blood was taken from individuals with optimum vitamin D levels to obtain T-PRF membranes
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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
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From enrollment to the end of treatment at 3 months
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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.
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From enrollment to the end of treatment at 3 months
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T-PRF Degradation of Membranes
Time Frame: From enrollment to the end of treatment at 3 months
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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
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From enrollment to the end of treatment at 3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AibuIBU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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