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临床试验/NCT03135626
NCT03135626已完成3 期

Comparison of The Success Rates of Four Different Pulpotomy Techniques

Istanbul University0 个研究点目标入组 38 人开始时间: 2013年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
38
主要终点
Total success rate

研究概览

简要总结

This randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.

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
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients were eligible if they were 5 to 7 years old, healthy and cooperative, and had at least four carious primary molars, each of which was in a different quadrant and required a pulpotomy. The criteria for the selection of the teeth to be included in the study were presence of deep caries, presence of at least two-thirds of the root length radiographically and being restorable.

排除标准

  • The exclusion criteria were the presence of 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) space, furcal or periapical radiolucency and teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. Teeth without permanent successor were not also included in the study.

研究组 & 干预措施

Biodentine

Experimental

Biodentine pulpotomy agent

干预措施: Biodentine (Drug)

ProRoot MTA

Experimental

ProRoot MTA pulpotomy agent

干预措施: ProRoot (Aggregate) (Drug)

MTA Plus

Experimental

MTA Plus pulpotomy agent

干预措施: MTA Plus (Drug)

Ferric Sulfate 20% Dental Gel

Active Comparator

Ferric Sulfate %20 Dental Gel pulpotomy agent

干预措施: Ferric Sulfate 20 % Dental Gel (Drug)

结局指标

主要结局

Total success rate

时间窗: 24 months after pulpotomy treatment

Number of molars with both clinically and radiographically successful

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

Yeliz Guven

Dr

Istanbul University

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