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临床试验/NCT03395496
NCT03395496已完成早期 1 期

Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up

Istanbul University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
200
试验地点
1
主要终点
Total success rate

研究概览

简要总结

The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A total of 200 primary molars with deep caries were treated with two different pulpotomy medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion criteria for tooth selection were no clinical and radiographic evidence of pulp pathology. During 36 months of follow-up at 3-month intervals, clinical and radiographic success and failures were recorded.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • no clinical and radiographic evidence of pulp pathology,
  • no clinical and radiographic symptoms,
  • no history of spontaneous pain and tenderness,
  • no percussion, swelling or sinus tracts and pathologic mobility.

排除标准

  • any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL)
  • furcal or periapical radiolucency teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure.
  • without permanent successor

研究组 & 干预措施

ProRoot MTA

Experimental

Dental Materials

干预措施: Biodentine (Drug)

Biodentine

Experimental

Dental materials

干预措施: Biodentine (Drug)

Biodentine

Experimental

Dental materials

干预措施: ProRoot (Aggregate) (Drug)

ProRoot MTA

Experimental

Dental Materials

干预措施: ProRoot (Aggregate) (Drug)

结局指标

主要结局

Total success rate

时间窗: 12 months after pulpotomy treatment

次要结局

  • Total success rate(24 months after pulpotomy treatment)

研究者

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

Mine Koruyucu

Principal Investigator

Istanbul University

研究点 (1)

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