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临床试验/NCT05442320
NCT05442320已完成不适用

Influence of Different Toothpaste on Fluoride Concentration in Nails and Dental Fluorosis

University of Ljubljana0 个研究点目标入组 342 人开始时间: 2010年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
342
主要终点
Dental fluorosis

研究概览

简要总结

To determine fluoride concentration in fingernails and estimate if there is a correlation between fluoride concentration in fingernails and fluoride concentration in toothpaste used. In addition, fluorosis of permanent incisors will be evaluated at 13 years of age and correlated with toothpaste fluoride concentration.

详细描述

Toothpaste with 1000 ppm fluoride and above are more effective in a caries prevention in comparison to toothpastes with lower fluoride concentration or to placebo. Higher fluoride concentrations in toothpastes increase risk for development of tooth fluorosis. Children in first three years of life are most susceptible due to formation of permanent incisors and first molars in this period, beside younger children ingest more toothpaste compared to older children. Fluoride exposure can be measured in nails, where the average plasma fluoride concentration is reflected. The aim of our study was to determine fluoride concentration in fingernails and estimate if there is a correlation between fluoride concentration in fingernails and fluoride concentration in toothpaste used. In our study were included parents and children who had participated in previous studies from parenting class until children's 3 years of age. At that time children were randomly assigned to one of two groups, of which one was being given a toothpaste with 500 ppm fluoride and the other with 1000 ppm fluoride. Children were examined regularly until the age of 3. Children were invited to participate in another clinical examination at 4 years of age. At the time of examination parents were asked to fulfil a questionnaire about oral hygiene habits and a sample of children's fingernails were taken. A questionnaire fulfilled 200 parents, 169 children were examined, finger nail fluoride was analysed by using a gas chromatography method in 161 children. We determined that in 76 % the toothpaste chosen was not appropriate according to EAPD guidelines, 66 % parents was using toothpaste with 500 ppm fluoride for their children. The mean fingernail concentration was 1,43 ng/mg (SD = 0,08). The difference between groups using toothpastes with different fluoride concentrations, and compared with other factors, was not statistically significant. The mean concentration of fluoride in nails of our test group was low compared to reported values in similar studies and there was no significant difference between groups regarding to toothpaste used.

In addition, fluorosis of permanent incisors will be evaluated at 13 years of age and correlated with toothpaste fluoride concentration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Same packages of toothpastes with different concentration Key known only to principal investigator

入排标准

年龄范围
0 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • participation in parenting class
  • normal pregnancy

排除标准

  • chronic systemic diseases
  • genetic conditions
  • complications at delivery

结局指标

主要结局

Dental fluorosis

时间窗: 6 years after permanent incisor eruption

Dean index

次要结局

  • Fingernails fluoride concentration(4 years of age)

研究者

申办方类型
Other
责任方
Sponsor

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