EUCTR2008-008594-58-DE进行中（未招募）不适用
In situ mineral change and fluoride retention ofsound and demineralized enamel in high cariogenicmilieus following the single application of a 1.25%-fluoride or a placebo gel.
GABA International AG0 个研究点开始时间: 2009年5月5日最近更新:
适应症
相关药物
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 informed consent
- •Healthy volunteers
- •Age 18 - 60 years
- •Presence of at least 20 teeth excluding the wisdom teeth
- •Healthy or prosthetically, conservatively and periodontally
- •restored dentition
- •Average oral hygiene (cleaning the teeth at least twice a day)
- •Agreement of test subject not to use any oral hygiene products
- •other than the study products and toothpaste provided for the
- •duration of the study; the use of dental floss and interdental brush
- •Flow rate of stimulated saliva = 0.7 ml/min (Dentobuff Kit)
- •Moderate to high buffer capacity of saliva
- •Woman of childbearing potential: highly effective method of
- •birth control during the whole study
- •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 emergency treatment
- •Known hypersensitivity or allergy to study products and standard
- •toothpaste ingredients and/or dental material used in the present
- •Unphysiological mobility of the teeth
- •Pathological changes of the oral mucosa, e.g. acute ulcerating
- •gingivitis, acute herpetic gingivostomatitis, recurrent aphthous
- •ulceration or systemic illnesses with oral manifestations
- •Use of highly concentrated fluoride products like gels, tablets,
- •varnishes, fillings etc. or of erosive bronchiolytics or
- •antiasthmatics within 30 days prior to the planned insertion of the
- •intra-oral specimen holder and during the whole study
- •Known pregnancy or breast feeding during the course of the
- •Participation in a clinical trial or receipt of an investigational
- •compound/treatment within the last 30 days
- •Antibiotic therapy within the past 3 months
- •Eating disorders (e.g. bulimia, anorexia nervosa)
研究者
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