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临床试验/EUCTR2005-005184-29-DE
EUCTR2005-005184-29-DE进行中(未招募)不适用

Prevention of incipient carious lesions (white spot lesions) in patients with fixed orthodontic appliances following the application of elmex® gelée

GABA GmbH0 个研究点目标入组 314 人开始时间: 2006年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
314

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Treatment plan: minimum of 10 teeth to be bonded labially
  • - At least 10 years old
  • - Highly effectively birth control for girls and women with child-bearing potential (e. g. implants, oral contraceptives, injectables, plasters, sexual abstinence, vasectomised partner, IUDs)
  • - Written declaration of informed consent
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Known allergy to one of the components of the test products
  • - Handicapped patients who have difficulties brushing their teeth
  • - Pathological desquamation changes
  • - Known Pregnancy
  • - Breast feeding.
  • - Eating disorders (e.g. bulimia, anorexia nervosa).
  • - Disease that effects dental hard tissue (i.e. severe fluorosis, amelogenesis or dentinogenesis imperfecta)
  • - Participation in another clinical trial either currently or within the last 30 days.

研究者

发起方
GABA GmbH

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