Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Calcium content of plaque
研究概览
简要总结
The aim of this pilot study is to analyze if a hydroxyapatite-containing mouth gel has an influence on the calcium content of plaque.
详细描述
>= 20 subjects (7-11 years) use the hydroxyapatite-containing mouth gel for 3 days (3x per day); without using any other oral care product at this time. A dentist applies the gel on all teeth. At baseline and after 3 days plaque will be collected from buccal and labial surfaces (except surfaces with tartar). A "split-mouth" concept will be used:
Subjects in group A:
Baseline plaque collection: quadrant 1 and 4 Plaque collection after 3 days: quadrant 2 and 3
Subjects in group B:
Baseline plaque collection: quadrant 2 and 3 Plaque collection after 3 days: quadrant 1 and 4 (The time between last application of the gel and plaque collection will be 1 h) The plaque will be dried and afterwards the calcium content of the plaque will be quantitively analyzed by atomic absorption spectroscopy (AAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Girls and boys (7-11 years)
- •Visible plaque
- •>= 4 teeth
- •Good overall health
排除标准
- •Allergic to one or more ingredients of the mouth gel
- •Medication intake (e.g. antibiotics)
- •Any other reason that, in the opinion of the investigator, disqualifies the subject from participating in the study
结局指标
主要结局
Calcium content of plaque
时间窗: 3 days
Analysis by atomic absorption spectroscopy (AAS)
次要结局
未报告次要终点
研究者
Dr. Joachim Enax
Senior Scientist Oral Care
Dr. Kurt Wolff GmbH & Co. KG