- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05343273
25-Hydroxyvitamin D Levels in Patients With Periodontitis (Stage III)
Total, Free, and Bioavailable 25-Hydroxyvitamin D Levels in Patients With Periodontitis (Stage III): A Case-Control Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
None Selected
-
Erzurum, None Selected, Turkey, 25240
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Without systemic disease,
- Had a least 14 teeth
Exclusion Criteria:
- Individuals with a history of systemic or topical oral antimicrobial therapy use in the last 3 months,
- Individuals with an allergy to any ingredient used in the study,
- Smokers,
- Pregnant or breastfeeding women,
- Using vitamin D,
- Individuals diagnosed with obesity
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy
|
blood collection for routine biochemical analysis
|
Periodontitis
|
blood collection for routine biochemical analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurements of 25(OH)D
Time Frame: Within one week of collecting blood samples from all participants.
|
Total 25(OH)D levels in serum samples will be measured by ELISA method, using the "Human 25-Dihydroxy vitamin D ELISA Kit" (BT LAB, Cat No: E1981Hu, China) in accordance with the manufacturer's instructions.
Results will be recorded in ng/mL.
|
Within one week of collecting blood samples from all participants.
|
Measurements of VDBP
Time Frame: Within one week of collecting blood samples from all participants.
|
VDBP levels in serum samples will be studied by ELISA (Enzyme Linked Immunosorbend Assay) method using Elabscience brand kit (Elabscience Biotechnology Co., Ltd).
Results will be recorded in (ug/mL.
|
Within one week of collecting blood samples from all participants.
|
Measurements of Albumin
Time Frame: Within one week of collecting blood samples from all participants.
|
Serum albumin levels (g/dL) will be measured on the Roche Cobas c702 instrument (Germany) using commercial kits.
|
Within one week of collecting blood samples from all participants.
|
Calculation of Bioavailable 25(OH)D
Time Frame: Within one week of collecting blood samples from all participants.
|
It will be calculated using calculations using affinity constants and calculated free 25(OH)D and measured albumin levels. Kalb = affinity constant between vitamin D and albumin = 6 x 10^5 M^-1 Bioavailable 25(OH)D concentration = (6 x 10^5 x [Albumin]+1) x calculated free 25(OH)D Results will be recorded in ng/mL. |
Within one week of collecting blood samples from all participants.
|
Calculation of Bioavailable Free 25(OH)D
Time Frame: Within one week of collecting blood samples from all participants.
|
It will be calculated using calculations using affinity constants and measured total serum 25(OH)D, VDBP and albumin levels. Kalb = affinity constant between vitamin D and albumin = 6 x 10^5 M^-1 KVDBP = affinity constant between vitamin D and VDBP = 7 x 10^8 M^-1 [Albumin] = serum albumin concentration = (serum albumin g/L) / 66.430 g/mol [VDBP] = serum vitamin D binding protein concentration = (serum VDBP g/L) / 58.000 g/mol Free 25(OH)D concentration = Total 25(OH)D / 1+(6 x 10^5 x [Albumin]) + (7 x 10^8 x [VDBP]) Results will be recorded in pg/mL. |
Within one week of collecting blood samples from all participants.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dental Plaque
Time Frame: Day 1
|
Plaque scores recorded by using the Silness&Löe Plaque Index PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically. PI 3: Heavy plaque accumulation is detected at the gin- gival margin and in the interdental spaces. |
Day 1
|
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
- 9099
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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-
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