ACTRN12621000166875终止未知
Assessment of BlueCheck’s diagnostic performance for detection of active initial enamel caries in an orthodontic cohort
Incisive Technologies Pty Ltd0 个研究点目标入组 56 人开始时间: 2021年2月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 56
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
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 Years 至 o limit（—）
- 性别
- All
入选标准
- •Healthy participants > 12 years of age undergoing fixed-appliance orthodontic treatment
- •will be recruited.
- •Able to read, understand and sign the Participant Information and Consent Form
- •If under 18 years of age, must have a legal guardian sign the Participant Information
- •and Consent Form
排除标准
- •Presence of oral ulcerations (chronic or acute)
- •Presence of exposed dentine on the reference tooth surfaces
- •Presence of carious lesions with cavitation on the reference tooth surfaces
- •Presence of developmental defects of enamel on the reference tooth surfaces
- •Allergic to meat or any of the components of BlueCheck or a history of alpha-gal
- •Unable or unwilling to participate in the required study procedures (e.g. due to religious,
- •moral, or ethical objection over exposure to cow-derived (non-Halal, non-Kosher)
- •material as is used in the manufacture of BlueCheck)
- •Currently receiving intensive remineralisation therapy (e.g. fluoride varnish, tooth
- •mousse), or have received such therapy within the last 1 month.
- •Pregnancy as disclosed by the participant
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