Low-fluoride Acidic Liquid Dentifrice in Non-fluoridated Communities: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Evaluation of the concentration of fluoride incorporated into the biofilm and nails 6 months after initiation of dentifrices use in non-fluoridated communities
研究概览
简要总结
The aim of this randomized clinical trial is to evaluate the effect of pH and fluoride concentration in liquid dentifrices in the control of dental caries in early childhood, in non-fluoridated area. This study also aims to assess the effect of the consistency of liquid dentifrices in the fluoride uptake in the plaque and the fluoride concentration in the toenails, to estimate the fluoride intake from these formulations.
详细描述
The study was carried out with schoolchildren living in a non-fluoridated area, with (A) or without (I) active caries lesions, were randomly allocated into 3 groups according to the LD used over 12 months: Group 1 (n=39-A/38-I): 550µgF/g-pH4.5, Group 2 (n=33-A/35-I) 1100µgF/g-pH7.0, Group 3 (n=33-A/34-I): 550µgF/g-pH7.0.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 2 to 4 years;
- •Not having participated in any other clinical study within 3 months prior to selection;
- •Not having very large carious lesions or dentin sensitivity during the study;
- •Signature of informed consent by the parents.
排除标准
- •Using orthodontic appliances
结局指标
主要结局
Evaluation of the concentration of fluoride incorporated into the biofilm and nails 6 months after initiation of dentifrices use in non-fluoridated communities
时间窗: 6 months
Samples of plaque and nails were analysed for fluoride using an ion-specific electrode after diffuusion with hexamethyldisiloxane-facilitated (HMDS)
次要结局
- New caries diagnostic criteria: caries progression/regression in caries-active children and caries progression in caries-inactive children after 12 months according to the type of dentifrice used in non-fluoridated communities(12 months)
研究者
Fabio Correia Sampaio
PhD
Federal University of Paraíba