Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel
试验速览
- 阶段
- 4 期
- 入组人数
- 314
- 试验地点
- 4
- 主要终点
- time and frequency of visually detected WSL (white spot lesions)
研究概览
简要总结
the objective of this phase IV study: to establish the efficacy of elmex gel with a fluoride concentration of 1.25% compared with placebo by determining prevention of white spot lesions in patients wearing fixed orthodontic appliances.
详细描述
314 healthy subjects undergoing orthodontic treatment will be examined. follow up will take place from bonding the appliance till debonding, at least 12 months and no more than 30 months.
tooth brushing with product (test product or control) once per week during the entire study.
4 times a year additional tray application of test product or control. subjects wiil clean their teeth with the toothpaste they usually use during the entire study.
toothbrush and a sandglass will be provided every 6 weeks
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •treatment plan: minimum of 10 teeth to be bonded labially at least 10 years old
- •written declaration of informed consent
排除标准
- •known allergy to components of test products
- •handicapped patients who have difficulties brushing their teeth
- •pathological desquamation changes
- •known pregnancy, breast feeding
- •eating disorders
- •disease that effect dental hard tissue
- •participation in another clinical trial either currently or within the lase 30 days
结局指标
主要结局
time and frequency of visually detected WSL (white spot lesions)
时间窗: 3 month
次要结局
- mineral loss according to QLF readings(3 month)
- Frequency and chronoloy of WSL(3 month)