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临床试验/NCT01571050
NCT01571050已完成1 期

Systemic Fluoride Bioavailability From Toothpastes Containing Calcium Carbonate or Silica as Abrasives

University of Campinas, Brazil1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: Fresh NaF/SiO2 toothpaste (Drug)

Purified water

Placebo Comparator

干预措施: Purified water (Drug)

Aged NaF/SiO2 toothpaste

Experimental

干预措施: Aged NaF/SiO2 toothpaste (Drug)

Fresh MFP/CaCO3 toothpaste

Experimental

干预措施: Fresh MFP/CaCO3 toothpaste (Drug)

Aged MFP/CaCO3 toothpaste

Experimental

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

发起方
University of Campinas, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Livia Maria Andaló Tenuta

Assistant Professor, Biochemistry and Cariology

University of Campinas, Brazil

研究点 (1)

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