跳至主要内容
临床试验/NCT01038817
NCT01038817已完成4 期

Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
179
试验地点
1
主要终点
incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles

研究概览

简要总结

This study questions the interest of fluoride varnish dental application in preventing tooth decay in a population of institutionalised elderly people.

详细描述

Application of fluoride varnish on one side of the mandibles (left or right, randomly selected) in a population of institutionalised elderly people.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • patient hospitalised in nursing home or long-stay hospital department
  • patient older than 18 years old
  • obtention of informed consent
  • 3 or more healthy or treated teeth on each side (left and right) of the mandibles

排除标准

  • patient in palliative care or end-of-life care
  • patient without social security affiliation
  • patient participating in another research dealing with dental care
  • contra-indication to fluoride varnish

研究组 & 干预措施

fluoride varnish

Active Comparator

Duraphat:

Application of fluoride varnish on one side of the mandibles (left or right, randomly selected)

干预措施: Duraphat (Drug)

结局指标

主要结局

incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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