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临床试验/NCT06871631
NCT06871631已完成不适用

Relationships Between Serum Vitamin D Levels and Osteocalcin and N-terminal Telopeptide Levels in Gingival Crevicular Fluid

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年6月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Osteocalcin Concentration in Gingival Crevicular Fluid (ng/mL)

研究概览

简要总结

This study examines the relationship between serum vitamin D levels and bone metabolism markers-osteocalcin and N-terminal telopeptide (NTx)-in gingival crevicular fluid (GCF) of periodontally healthy and periodontitis patients. A total of 120 male participants (60 healthy, 60 with periodontitis) aged 25-40 were included and categorized based on their serum vitamin D levels.

详细描述

Recent evidence suggests that vitamin D, a key regulator of bone metabolism, may play a role in periodontal health by influencing bone turnover markers such as osteocalcin and N-terminal telopeptide (NTx). This study aims to investigate the effects of serum vitamin D levels on these bone metabolism markers in gingival crevicular fluid (GCF) of periodontally healthy and periodontitis patients.

A total of 120 male participants aged 25-40 years were enrolled, comprising 60 periodontally healthy individuals and 60 patients diagnosed with periodontitis. Participants were further categorized into subgroups based on their serum vitamin D levels (0-10 ng/ml, 11-20 ng/ml, and 21-30 ng/ml). GCF samples were collected from maxillary premolar and molar sites and analyzed using enzyme-linked immunosorbent assay (ELISA) to measure osteocalcin and NTx concentrations.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • One hundred and twenty male patients, consisting of 60 periodontally healthy patients and 60 patients with periodontitis, aged between 25 and 40 years, non-smoking, who had not received periodontal treatment in the last 6 months, with no systemic diseases, and whose Vitamin D levels had been determined, were included in the study.

排除标准

  • Female individuals
  • Individuals with systemic diseases (Diabetes Mellitus, Hyperthyroidism, -Malabsorption, Liver and Renal Failure, or those receiving osteoporosis treatment)
  • Individuals who have undergone periodontal treatment within the last 6 months
  • Individuals on regular medication
  • Individuals who did not provide informed consent
  • Individuals with poor cooperation

结局指标

主要结局

Osteocalcin Concentration in Gingival Crevicular Fluid (ng/mL)

时间窗: At baseline (single time point)

Osteocalcin concentration will be determined using an enzyme-linked immunosorbent assay (ELISA) and expressed in ng/mL.

N-Terminal Telopeptide Concentration in Gingival Crevicular Fluid (nmol/L)

时间窗: At baseline (single time point)

NTx concentration will be measured using an ELISA and expressed in nmol/L.

Total Osteocalcin Levels in Gingival Crevicular Fluid (ng/ml)

时间窗: At baseline (single time point)

This measure assesses the total osteocalcin amount in gingival crevicular fluid. Absorbance values will be recorded using an ELISA reader, and total levels will be determined based on a standard curve.

Total N-Terminal Telopeptide Levels in Gingival Crevicular Fluid (nmol/L)

时间窗: At baseline (single time point)

This measure quantifies the total amount of N-Terminal Telopeptide in gingival crevicular fluid. The total amount is determined using ELISA and calculated based on a standard curve.

次要结局

  • Corelation between serum vitamin D levels (ng/ml) and osteocalcin (ng/ml) and N-terminal telopeptide levels (nmol/L) in gingival crevicular fluid(At baseline (single time point))
  • Periodontal clinical parameters (probing depth)(At baseline (single time point))
  • Periodontal clinical parameters (bleeding on probing)(At baseline (single time point))
  • Periodontal clinical parameters (clinical attachment level)(At baseline (single time point))

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Atanur Sarioglu

Research assistant

Ondokuz Mayıs University

研究点 (1)

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