NCT02874625招募中不适用
Randomized Clinical Trial in Children to Evaluate the Biocompatibility 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
- 200
- 试验地点
- 2
- 主要终点
- Urinary bisphenol A levels
研究概览
简要总结
In this randomized clinical trial, the bio-compatibility of 2 materials used for dental restorations will be compared: glass-ionomer vs resin-based composites.
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. Global alterations in DNA methylation and DNA hydroxymethylation levels will be determined using UPLC-MS/MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •one or more carious lesions in primary molars that require treatment
排除标准
- •carious lesions that already affected the dental pulp, large lesions requiring cusp replacement, presence of oral inflammatory conditions during the previous 2 weeks, carriage of a fixed or removable prosthesis/orthodontic appliance, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in previous 2 months, previous dental restorations
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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