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临床试验/NCT02776280
NCT02776280已完成4 期

Oral Fluoride Bioavailability by the Consumption of Meals Prepared With Fluoridated Water or Salt

University of Campinas, Brazil0 个研究点目标入组 12 人开始时间: 2015年7月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
12
主要终点
Fluoride concentration in saliva

研究概览

简要总结

This study will assess the concentration of fluoride in saliva and dental biofilm (fluid and solids) during and up to 2 hours after the consumption of typical Brazilian meals prepared with fluoridated water (0.7 ppm F) or fluoridated salt (250 mg F/kg). Typical Brazilian meals (rice, beans, meat with vegetables) will be prepared using fluoridated water, salt, or non-fluoridated water and salt. In an crossover design, twelve volunteers will eat 4.67 g of food/kg body weight of each meal, on fasting, during 15 min. Before the ingestion, unstimulated saliva and dental biofilm will be collected for determination of fluoride concentration. During the meal, 3 samples of the alimentary bolus (at 5, 10 and 15 min of mastication) will be collected for determination of fluoride concentration. Dental biofilm will be collected immediately after the ingestion of the meal. Saliva will then be collected after 5, 10, 15, 30, 60 and 120 min. All samples will be analyzed for fluoride using an ion-specific electrode. In order to standardize biofilm formation, during lead-in and wash-out periods, volunteers will: 1. brush their teeth with non-fluoride toothpaste; 2. refrain from brushing superior posterior teeth for 2 days before each phase; and 3. chew sucrose-containing chewing gum 5 times/day, for 10 min, during the 2 days prior to each phase. Groups will be compared by ANOVA and Tukey test.

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 33 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • good general health
  • good oral health
  • not having used topical fluorides in the last 2 months

排除标准

  • poor general health
  • poor oral health
  • breastfeeding
  • expecting mothers

结局指标

主要结局

Fluoride concentration in saliva

时间窗: up to 120 min after meal

Fluoride concentration in dental biofilm

时间窗: up to 120 min after the meal

Fluoride concentration in the alimentary bolus

时间窗: up to 15 min after start of the meal

次要结局

未报告次要终点

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

University of Campinas, Brazil

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