Enamel Caries in Orthodontic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of developing enamel caries lesions
研究概览
简要总结
This randomized double-blind two arm controlled clinical trials evaluates the hypothesis that the regular use of a tooth paste containing microcrystalline hydroxylapatite provides a caries preventive effect in caries-susceptible individuals undergoing orthodontic therapy with fixed appliances which is comparable to the caries preventive effect provided by the regular use of a fluoridated tooth paste.
详细描述
Introduction
According to the criteria of evidence based medicine the use of fluoridated tooth paste as well as fluoridated mouth rinses are,with the exception of dietary control, the only proven measures for the prevention of dental caries.
Aim, Study Hypothesis
The aim of this randomized double-blind, two arm, controlled clinical trial is evaluation of the hypothesis that the regular use of a tooth paste containing microcrystalline particles of hydroxylapatite in caries-active subjects under orthodontic therapy with fixed appliances will provide at least a comparable extent of caries prevention as the regular use of fluoridated tooth paste during an observation period of 6 months.
Material and Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy juveniles and young adults with caries-promoting mutans streptococci colonization seeking orthodontic therapy with fixed orthodontic appliances
排除标准
- •Oral ulcers
- •Caries lesions on the buccal aspects of teeth 15-25
- •Unrestored caries on any tooth
- •Regular use of medications interfering with salivary flow and/or gingival inflammation
结局指标
主要结局
Number of developing enamel caries lesions
时间窗: 168 days (24 weeks)
Recording of newly developing enamel caries lesions according to the International Caries Detection and Assessment System (ICDAS)
次要结局
- Plaque Coverage using the Plaque Index(168 days (24 weeks))
- Gingival Inflammation using the Gingival Index(168 days (24 weeks))
- Mutans Streptococci Colonization(168 days (24 weeks))
研究者
Prof. Dr. Ulrich Schlagenhauf
Chairman Dept. of Periodontology
Wuerzburg University Hospital