Clinical Study of Tooth Enamel Remineralization Using DoReMin Product
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- ICDAS II visual scoring system (Codes)
研究概览
简要总结
The study is designed as a split-mouth randomised controlled study. This means within the mouth of one patient one tooth with an initial lesion is treated and coated with the Experimental Remineralization product whereas another comparable tooth with an initial lesion is left untreated. Patients are included upon meeting the inclusion criteria as defined for this clinical trial. In the test group, a remineralization of the incipient carious lesion is expected. The patients are recalled after 1 day (optional), 4 weeks, 4 months and finally after 1 year to evaluate the untreated and treated lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least two incipient carious lesions on the buccal or oral surface of a permanent tooth. Neighbouring teeth should not be in two different groups. There is no maximum amount of lesions.
- •Active caries lesion
- •Patient at risk of caries
- •Vital teeth
排除标准
- •Pregnancy
- •Enamel detachment at the site of investigation
- •Allergies (DoReMin)
- •Chronic diseases
结局指标
主要结局
ICDAS II visual scoring system (Codes)
时间窗: Baseline to 1 Year
Evaluation of the clinical status of the lesions: 0: Sound tooth surface: No evidence of caries after 5 sec air drying 1. First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying 2. Distinct visual change in enamel visible when wet, lesion must be visible when dry 3. Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying 4. Underlying dark shadow from dentin 5. Distinct cavity with visible dentin 6. Extensive (more than half the surface) distinct cavity with visible dentin
White Spot Measurement
时间窗: Baseline to 1 Year
Analysis of incipient caries or demineralized enamel by using laser fluorescence technology.
次要结局
未报告次要终点