25-Hydroxyvitamin D Levels in Patients With Periodontitis (Stage III)

Study Overview
=================
Brief Summary
-----------------
Periodontitis; is an inflammatory disease of tissues characterized by bone destruction around the teeth. Vitamin D plays an important role in several inflammatory diseases by promoting the expression of inflammatory cytokines such as interleukin IL-1, IL-6, and IL-1β, which are directly related to periodontal attachment loss and bone demineralization. These facts suggest that vitamin D may be associated with periodontal disease. Many studies have been conducted on the relationships between serum 25-hydroxyvitamin D (25(OH)D) levels, periodontal disease, and tooth loss. However, as far as we know, there is no study on the relationship between periodontitis and free and bioavailable 25 (OH) vitamin D. In our study, over the age of 35; two groups will be formed, consisting of 40 healthy and 40 periodontitis individuals. Serum total 25 (OH) D level and vitamin D binding protein level will be analyzed by ELISA method, and bioavailable 25 (OH) D level will be calculated using total 25 (OH) D and vitamin D binding protein levels. The aim of this study; To evaluate the total, free and bioavailable 25 (OH) vitamin D levels of patients with periodontitis by comparing them with healthy controls, and to investigate whether bioavailable 25 (OH) D plays a role in the pathogenesis of periodontitis or can be a simple marker of disease activity in the light of these findings.

Official Title
-----------------
Total, Free, and Bioavailable 25-Hydroxyvitamin D Levels in Patients With Periodontitis (Stage III): A Case-Control Study

Conditions
-----------------
Vitamin D Deficiency, Periodontitis

Intervention / Treatment
-----------------
* Diagnostic Test: taking a blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br> | Diagnostic Test: taking a blood sample<br>* blood collection for routine biochemical analysis<br>|
| Periodontitis<br> | Diagnostic Test: taking a blood sample<br>* blood collection for routine biochemical analysis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of 25(OH)D | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total 25(OH)D, Bioavailable 25(OH)D, Free 25(OH)D, Periodontitis