Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fluoride concentration in biofilm fluid
研究概览
简要总结
Fluoride toothpaste has been associated not only with declining dental caries prevalence but also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride toothpaste use, the purpose of this study is to evaluate the availability of fluoride concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from ingested toothpastes (with potential to cause dental fluorosis), in a sample of young Brazilian children using toothpaste formulations representative of those available and most used by this age-group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 3 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health
- •Good oral health
排除标准
- 未提供
研究组 & 干预措施
Non-fluoride toothpaste
干预措施: Toothpaste (Drug)
Toothpaste 550 µg F/g (NaF/SiO2)
干预措施: Toothpaste (Drug)
Toothpaste 1100 µg F/g (NaF/SiO2)
干预措施: Toothpaste (Drug)
Toothpaste 1450 µg F/g (MFP/CaCO3)
干预措施: Toothpaste (Drug)
结局指标
主要结局
Fluoride concentration in biofilm fluid
时间窗: 30min
Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm fluid will be determined by a fluoride electrode adapted for microanalysis.
Urinary fluoride excretion
时间窗: 8h
Urine will be collected at two time-points, either before the use of the toothpaste or at the last day of use, in each experimental phase. Fluoride concentration was determined by an inverted ion-specific fluoride electrode and fluoride excretion will be measured by fluoride/cratinine ratio (mg F/mg creatinine).
次要结局
- Fluoride concentration in biofilm solid(30min)
- Fluoride concentration in saliva(30min)
- Amount of toothpaste ingested(January 2013 to July 2013)
研究者
Livia Maria Andaló Tenuta
Assistant Professor, Biochemistry and Cariology
University of Campinas, Brazil