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临床试验/NCT02291120
NCT02291120Unknown4 期

MEDCEM PC and MTA in Pulpotomies of Primary Molars

Universitat Internacional de Catalunya2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
4 期
入组人数
80
试验地点
2
主要终点
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 MEDCEM PC and MTA 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
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • healthy children
  • 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
  • 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

Clinical success

时间窗: 24 months

No pain, no swelling, no fistula or sinus tract, no pathologic mobility

Radiographic success

时间窗: 24 months

No internal root resorption progressing into the bone, no external root resorption, no furcation and/or periapical bone destruction

次要结局

未报告次要终点

研究者

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

Cristina Cuadros

Master's Program Director in Pediatric Dentistry

Universitat Internacional de Catalunya

研究点 (2)

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