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临床试验/NCT02486458
NCT02486458已完成早期 1 期

Retention of Fluoride Formed on Enamel by Fluoride Gel or Varnish Application and Its Release to Dental Biofilm Fluid - in Vivo Study

University of Campinas, Brazil1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Change in fluoride concentration in enamel days after fluoride application

研究概览

简要总结

The anticaries effect of professional fluoride application has been associated with the formation of calcium fluoride-like products ("CaF2") on dental surface, which may function as a slow release fluoride reservoir. Among professional fluoride products, fluoride gel and varnish are the most important, and have different soluble fluoride concentrations, pHs and vehicles. Although the concentration of fluoride formed on enamel after the use of both is similar, the retention of these reaction products is unknown. Also, it is unknown the capacity of these reservoirs to enhance dental biofilm fluid with fluoride. Moreover, the effect of the varnish application time on these parameters is unknown. Therefore, the aim of this study is to compare the capacity of fluoride gel and varnish to form fluoride reservoirs on enamel and increase dental biofilm fluid fluoride concentration with time. Rapid biofilm-forming individuals will be selected to participate and divided into 4 experimental groups: 1. Negative control: no treatment; 2. Varnish 4 hours: fluoride varnish will be applied and kept on teeth for 4 hours; 3. Varnish 24 h: fluoride varnish will be applied on teeth and kept for 24 h; and 4. Gel: Fluoride gel will be applied on teeth. Microbiopsies of enamel will be obtained by a microbiospy technique to assess fluoride concentration before, 7 and 28 days after the treatments. Dental biofilm will be collected before and 3, 7, 14 and 28 days after treatments. Fluoride concentration on enamel and in the biofilm fluid will be determined by an ion-specific electrode. Data will be analyzed statistically comparing the groups and collection times.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good general health
  • Good oral health
  • At least 5 teeth in each hemiarch
  • All 4 superior incisors in the mouth
  • Rapid biofilm forming

排除标准

  • Pregnancy
  • Intake of medication that reduces salivary flow
  • Chronic diseases
  • Orthodontic appliances
  • Dental prosthesis
  • Allergy to fluoride varnish components

研究组 & 干预措施

Varnish 4 h

Experimental

Fluoride varnish will be applied on teeth and removed after 4 hours

干预措施: 5% sodium fluoride varnish (Drug)

Varnish 24 h

Experimental

Fluoride varnish will be applied on teeth and removed after 24 hours

干预措施: 5% sodium fluoride varnish (Drug)

Fluoride Gel

Experimental

Fluoride gell will be applied on teeth and removed after 4 minutes

干预措施: 1.23% sodium fluoride acidic gel (Drug)

结局指标

主要结局

Change in fluoride concentration in enamel days after fluoride application

时间窗: Up to 28 days

Change in fluoride concentration in dental biofilm fluid days after fluoride application

时间窗: Up to 28 days

次要结局

  • Change in fluoride concentration in whole biofilm days after fluoride application(Up to 28 days)

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

DDS, MSc, PhD

University of Campinas, Brazil

研究点 (1)

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