Effectiveness of an ICCMS™ Caries Management Program. A Schoolchildren Multicenter Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Evolution of ICCMSTM caries likelihood after 1 and 3 years.
研究概览
简要总结
The aim of this study is to compare in schoolchildren the effectiveness of an updated caries management program based on the current caries paradigm with the ICCMS™ system (International Caries Classification and Management System) versus an adjusted Colombian dental public health service caries management program, in terms of: 1- caries risk probability, 2- caries lesions, 3- parents' knowledge, attitudes and practices regarding children's oral health.
Null hypothesis: the caries management program based on its current paradigm offers the same degree of effectiveness than the conventional caries management program.
Alternative hypothesis: the caries management program based on its current paradigm offers a different degree of effectiveness than the conventional caries management program.
详细描述
This study counts with ethical approval from the Ethics Board in Universidad El Bosque (UEB 008-2014).
Population:
The study population will be 6-7 year-old schoolchildren from the six participant dental schools.
Baseline examination:
The baseline examination will be conducted by the site coordinator examiner. Once the informed consent is signed by the parents and the children give their acceptance, a comprehensive examination will be performed, including:
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, Investigator)
入排标准
- 年龄范围
- 6 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children from 6 to 7 years old
- •Informed consent signed
- •Children in standard good general health
排除标准
- •Children with physical disability and/or cognitive diseases
- •Children whose family will is planning to move from the city in the following 36 months
- •Children with orthopedic/orthodontic appliances at baseline
结局指标
主要结局
Evolution of ICCMSTM caries likelihood after 1 and 3 years.
时间窗: up to 36 months
Change in ICCMSTM caries likelihood subjects' distribution after 1 and 3 years
次要结局
- Presence of new caries lesions in terms of ICCMSTM categories after 1 and 3 years.(up to 36 months)
- Number of appointments after 1 and 3 years.(up to 36 months)
- Progression of existing caries lesion in terms of ICCMSTM categories after 1 and 3 years.(up to 36 months)
研究者
Stefania Martignon
Principal Investigator
Universidad El Bosque, Bogotá