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临床试验/NCT05343273
NCT05343273已完成不适用

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

Ataturk University1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2022年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
Calculation of Bioavailable 25(OH)D

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Without systemic disease,
  • Had a least 14 teeth

排除标准

  • 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,
  • Pregnant or breastfeeding women,
  • Using vitamin D,
  • Individuals diagnosed with obesity

结局指标

主要结局

Calculation of Bioavailable 25(OH)D

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Dental Plaque(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tugba Aydin

Assistant Professor

Ataturk University

研究点 (1)

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