PRFT-PrfNCT06870786
Effect of Vitamin D Deficiency on the Structure of Titanium Platelet-Rich Fibrin
A study testing Vitamin D (Cholecalciferol ) in people with PRF and Vitamin D Deficiency, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PRF, Vitamin D Deficiency, Vitamin Deficiency
- What is being tested?
- Vitamin D (Cholecalciferol )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2021to 2 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Periodontology, Faculty of Dentistry, Bolu Abant İzzet Baysal University,
Bolu, Bolu, 14100
About this study
Official title: 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.
Read the 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.
- Conditions
- PRF, Vitamin D Deficiency, Vitamin Deficiency
- Being tested
- Vitamin D (Cholecalciferol )
- Medical subject headings
- Vitamin D Deficiency, Avitaminosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (Cholecalciferol )Dietary supplement
Evaluation of T-PRF membrane structures obtained from the blood of patients before and after vitamin D supplementation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (2)
Scanning Electron Microscope (SEM) Examination
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.
Measured: From enrollment to the end of treatment at 3 months
T-PRF Degradation of Membranes
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
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start21 Jan 2021
- Primary completion15 May 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRFStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra ATEŞ, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870786
- Sponsor's protocol ID
- AibuIBU
- Acronym
- T-Prf
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Deficiency on the Structure of Titanium Platelet-Rich Fibrin(T-Prf)
- ClinicalTrials.gov ID
- NCT06870786
- Acronym / sponsor ID
- T-Prf / AibuIBU
- Conditions
- PRF, Vitamin D Deficiency, Vitamin Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with vitamin D deficiency | Experimental | Dietary Supplement: Vitamin D (Cholecalciferol )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. |
| Vitamin D level is optimal | No intervention | –Blood was taken from individuals with optimum vitamin D levels to obtain T-PRF membranes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D (Cholecalciferol )Evaluation of T-PRF membrane structures obtained from the blood of patients before and after vitamin D supplementation. | Dietary supplement | with vitamin D deficiency |
Primary outcome
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
2 secondary outcomes
Scanning Electron Microscope (SEM) Examination
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D (Cholecalciferol ) in people with PRF and Vitamin D Deficiency, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microscopic analysis (time frame: From enrollment to the end of treatment at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.