Evaluation of a Low-fluoride Anticaries Toothpaste Containing an Innovative Calcium Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Surface Microhardness
研究概览
简要总结
The purpose of this trial is to evaluate the anticaries remineralizing potential of a toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model, whereby approved human participants will wear an orthodontic appliance fitted with an enamel specimen for the duration of a leg (28 days). There will be two test legs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30 adult subjects (between 18-50 years of age)
排除标准
- 未提供
研究组 & 干预措施
G1
500 ppm F Test Toothpaste
干预措施: Fluorides, Topical (Drug)
G2
1100 ppm F Control Toothpaste
干预措施: Fluorides, Topical (Drug)
结局指标
主要结局
Surface Microhardness
时间窗: 30 days
Strength measurements made at the enamel surface of the enamel specimen
Transverse Microradiography
时间窗: 30 days
X-ray analysis of enamel lesion
Cross-Sectional Microhardness
时间窗: 30 days
Strength measurements made within the enamel lesion of the enamel specimen
次要结局
未报告次要终点
研究者
Dr. Robert L. Karlinsey
Managing Member
Indiana Nanotech, LLC