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临床试验/EUCTR2004-002366-38-DE
EUCTR2004-002366-38-DE进行中(未招募)不适用

Fluoride uptake and remineralisation of incipient carious lesions following the application of fluoride fluids with different fluoride concentrations -

GABA GmbH0 个研究点开始时间: 2004年10月4日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • Written declaration of informed consent
  • Age 18-60 years
  • At least 20 teeth
  • Good general health, as assessed by investigator
  • Healthy or prosthetically, restored and periodontally-sound dentition
  • Average oral hygiene (cleaning the teeth at least twice a day)
  • Agreement of test subjects not to use any oral hygiene products other than the test products and toothpaste provided for the duration of the study; the use of non-fluoridated oral hygiene agents is allowed
  • Flow rate of stimulated saliva = 0.7 ml/min
  • Moderate to high buffer capacity of saliva
  • Are the trial subjects under 18? no
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Ongoing oral or dental treatment except for emergency treatment
  • Known allergic reaction to an oral hygiene product and/or medication and/or dental material previously used in the mouth or pharynx
  • Existing allergy to one of teh components of the test products or the standard toothpaste
  • Unphysiological mobility of the teeth
  • Pathological changes of the oral mucusa, eg. acute ulcerating gingivitis, acute herpetic gingivostomatitis, recurrent aphthous ulceration or systemic illnesses with oral manifestations
  • Use of fluoride-containing products (Pastes, mouthrinses) within 14 days prior to the introduction of the intra-oral appliances
  • Use of fluoride-containing products: gels, tablets, varnishes, fillings etc., or of erosive bronchiolytics or anti-asthmatics within 30 days prior to the introduction of the intra-oral specimen holder
  • Pregnancy or breast feeding
  • Participation in another clinical trial either currently or within the last 30 days
  • Antibiotic therapy within the past 3 months
  • Any non-permitted therapy
  • Eating disorders (e.g.bulimia, anorexia nervosa)

研究者

发起方
GABA GmbH

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