DRKS00012941已完成4 期
Effect of Curodont™ Repair in Patients with Buccal Carious Lesions: A Mono-centre, Controlled, Split-mouth, Single-blinded, Randomised, Post-marketing Study - P11-4-BC
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- credentis ag
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 10 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Two buccal carious lesions which do not require operative intervention
- •Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
- •Patients must be able and willing to observe good oral hygiene throughout the study
- •= 20 teeth and a plaque index of < 20%
- •Age = 10 years and = 65 years
- •Willing and able to attend the on-study visits
- •Willing and able to understand all study-related procedures
- •Written informed consent before participation in the study
排除标准
- •Secondary caries lesion on tooth
- •Enamel aberration
- •Carious lesions due to orthodontic treatment on tooth
- •Evidence of tooth erosion (due to excessive acidic drink consumption or reflux)
- •History of head and neck illnesses (e.g. head/neck cancer)
- •Any pathology or concomitant medication affecting salivary flow or dry mouth
- •Any metabolic disorders affecting bone turnover
- •Concurrent participation in another clinical trial with an investigational drug or device or participation in another clinical trial with an investigational drug or device within 30 days prior to study entry
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