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

Completed

• Conditions: Periodontitis; Vitamin D Deficiency
• Interventions: Diagnostic Test: taking a blood sample

• Registration Number: NCT05343273
• Lead Sponsor: Ataturk University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-25
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	taking a blood sample	-
Periodontitis	taking a blood sample	-

Primary Outcome Measures

Name	Time	Method
Calculation of Bioavailable 25(OH)D	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.
Measurements of 25(OH)D	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.
Calculation of Bioavailable Free 25(OH)D	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.
Measurements of VDBP	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.
Measurements of Albumin	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.

Secondary Outcome Measures

Name	Time	Method
Dental Plaque	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.

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, None Selected, Turkey