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临床试验/NCT01978041
NCT01978041已完成1 期

Fluoride Bioavailability in Plasma and Saliva After Ingestion of Water or Foods Prepared With Fluoridated Water

University of Campinas, Brazil2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年1月1日最近更新:
适应症

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
2
主要终点
Area under the curve of plasma fluoride concentration versus time after water or food ingestion

研究概览

简要总结

The importance of fluoridated water to control caries is well recognized. Although the mode of action of fluoridated water is known (related to a slight increase in fluoride concentration in saliva/dental biofilm in individuals living in fluoridated areas), the kinetics of fluoride concentration in saliva after ingestion of food prepared with fluoridated water, either from fluoride remaining in the oral cavity after mastication, or from fluoride returning from salivary secretion is not known in details. Therefore, the aim of this study is to assess fluoride bioavailability after ingestion of food prepared with fluoridated water. The study will be in vivo, crossover and double blind, in which 12 adult volunteers will participate. In 4 experimental phases, volunteers will ingest: a. a typical Brazilian meal cooked with non-fluoridated water (<0.1 ppm F); b. a typical Brazilian meal cooked with fluoridated water (1 ppm F); c. non fluoridated water (<0.1 ppm F) and d. fluoridated water (1 ppm F). Immediately before and 5, 10, 15, 30, 45, 60, 120, 180 minutes after the ingestion, a blood sample will be collected by digital puncture, and a sample of unstimulated saliva will be collected. Fluoride concentration in the samples will be determined by an ion specific electrode adapted for microanalysis. Results will be analyzed by ANOVA, with significance limit of 5%.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 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
  • Systemic diseases
  • Use of drugs that alter salivary flow rate/renal excretion

结局指标

主要结局

Area under the curve of plasma fluoride concentration versus time after water or food ingestion

时间窗: 180 minutes

A microsample of blood will be collected by digital puncture before and 5, 10, 15, 30, 45, 60, 120 and 180 min after treatments, to calculate the area under the curve of fluoride concentration in the plasma

次要结局

  • Maximum fluoride concentration in saliva after water or food ingestion(180 minutes)
  • Maximum fluoride concentration in plasma after water or food ingestion(180 minutes)
  • Area under the curve of salivary fluoride concentration versus time after water or food ingestion(180 minutes)

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

Associate Professor, Biochemistry and Cariology

University of Campinas, Brazil

研究点 (2)

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