NCT01591278Unknown4 期
Clinical and Radiographic Outcomes of MTA and Biodentine in Pulpotomized Primary Molars. A Randomized Clinical Trial
Cristina Cuadros2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年3月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of molars with clinical success
研究概览
简要总结
The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MTA and Biodentine when used as pulp dressings following pulpotomy in human primary molars.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •molars showing:
- •symptomless exposure of vital pulp by caries
- •no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction)
- •the possibility of proper restoration of the teeth
- •no physiological resorption of more than one-third of the root
排除标准
- •presence of systemic pathology and any history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents
结局指标
主要结局
Number of molars with clinical success
时间窗: 12 months
Number of molars with radiographic success
时间窗: 6 and 12 months
次要结局
- Number of molars with no evidence of radicular radiolucency(6 and 12 months)
- Number of molars with no evidence of internal resorption(6 and 12 months)
- Number of molars with no evidence of external resorption(6 and 12 months)
- Number of molars with no evidence of furcation radiolucency(6 and 12 months)
- Number of molars with no symptoms of pain(6 and 12 months)
- Number of molars without swelling(6 and 12 months)
- Number of molars without fistulation(6 and 12 months)
- Number of molars without pathological mobility.(6 and 12 months)
研究者
Cristina Cuadros
Cristina Cuadros Fernández
Universitat Internacional de Catalunya
研究点 (2)
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