NCT02874599招募中不适用
Cohort Biomonitoring Study to Evaluate the Biocompatibilty of Resin-based Dental Materials
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Urinary bisphenol A levels
研究概览
简要总结
Adult patients who require multiple dental restorations will be included in this study. Urine and saliva samples will be taken for determination of bisphenol A levels at several time points, and for analysis of the estrogenic activity using ERE-CALUX.
Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit. We will determine global alterations in DNA methylation and DNA hydroxymethylation levels using UPLC-MS/MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian, adults,
排除标准
- •acute or chronic medical condition, presence of oral inflammatory conditions during the previous 2 weeks, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in the previous 2 months, smoking and consumption of alcohol
结局指标
主要结局
Urinary bisphenol A levels
时间窗: 1 year
%DNA hydroxymethylation
时间窗: 6 months
Salivary bisphenol A levels
时间窗: 1 year
%DNA methylation
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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