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临床试验/NCT01811420
NCT01811420已完成不适用

Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
restauration evaluation

研究概览

简要总结

To evaluate the efficacy of a papain-based gel in caries removal.

详细描述

Twenty children with at least two carious molar teeth without pulpal involvement participated in this randomized clinical trial. A total of 40 teeth were randomly divided into two treatment groups: group A, papain-based gel; and group B, conventional technique. Data collection included the time required for caries removal, need for local anesthesia, degree of discomfort, changes in the number of viable bacteria, and clinical evaluation of glass ionomer-cement restorations 6-month post-treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial.
  • The caries were located on the occlusal surface.

排除标准

  • Children with pathological process of the dental tissue, with pulpal involvement

结局指标

主要结局

restauration evaluation

时间窗: 18 months

the restauration will be assessed by clinical examination for detection the current caries

次要结局

  • discomfort or pain(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lara Jansiski Motta

PhD Professor

University of Nove de Julho

研究点 (2)

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