Systemic Fluoride Bioavailability From Toothpastes Containing Calcium Carbonate or Silica as Abrasives
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area under the curve of salivary fluoride concentration versus time after toothpaste ingestion
研究概览
简要总结
The risk of dental fluorosis development is related to the systemic exposure to fluoride during enamel formation. Currently, diet and fluoride toothpastes are the main sources of fluoride to children at the age-risk for fluorosis development. However, when estimating the risk of fluorosis from toothpaste inadvertently ingested, it has not been considered the systemic fluoride bioavailability. Since some toothpaste formulations may contain part of fluoride as insoluble salts, the hypothesis behind this study is that only soluble fluoride in toothpastes would be absorbed when they are inadvertently ingested. To test that, adult volunteers will ingest a standardized dose of total fluoride from commercially available toothpastes, which present different concentrations of soluble fluoride. Fluoride systemic bioavailability will be assessed by the release of fluoride in saliva up to 3 hours after ingestion (as an indicator of blood fluoride) and by urinary fluoride excretion.
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
- 19 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health
- •Good oral health
- •Normal salivary flow rate
排除标准
- •Gastric disorders
- •Renal disorders
研究组 & 干预措施
Fresh NaF/SiO2 toothpaste
干预措施: Fresh NaF/SiO2 toothpaste (Drug)
Purified water
干预措施: Purified water (Drug)
Aged NaF/SiO2 toothpaste
干预措施: Aged NaF/SiO2 toothpaste (Drug)
Fresh MFP/CaCO3 toothpaste
干预措施: Fresh MFP/CaCO3 toothpaste (Drug)
Aged MFP/CaCO3 toothpaste
干预措施: Aged MFP/CaCO3 toothpaste (Drug)
结局指标
主要结局
Area under the curve of salivary fluoride concentration versus time after toothpaste ingestion
时间窗: 3 hours
Saliva will be collected before and up to 3 hours after ingestion of the toothpastes or negative control. Collections (during 3 min) will be made at 0 (immediately before ingestion), 15, 30, 45, 60, 120 and 180 min after ingestion.
次要结局
- Maximum concentration of fluoride in saliva after toothpaste ingestion(3 hours)
- Urinary fluoride excretion (24-h) after toothpaste ingestion(48 hours)
研究者
Livia Maria Andaló Tenuta
Assistant Professor, Biochemistry and Cariology
University of Campinas, Brazil
