NCT02201498已完成不适用
A New Technique for Primary Molar Pulpotomy : A Randomized Clinical Trial Comparing the Radiographic and Clinical Success of the Formocresol-zinc Oxide Eugenol Technique and the Biodentine Technique
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- clinical success
研究概览
简要总结
This is a RCT that will compare the clinical and radiographic success of pulpotomies on primary molars between the traditional technique (Formocresol/ZOE) and the new technique with Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 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
- Single (Participant)
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I and II
- •less than 1/3 of physiologic root resorption
- •asymptomatic tooth (with no history of symptoms)
- •no clinical or radiological sign of pathology
- •vital tooth, with carious pulpal exposure
- •hemostasis must be obtained simply with pressure in less than 5 min
- •teeth restored with stainless steel crowns
排除标准
- •more than 10 y.o.
- •symptomatic tooth (presently or history of symptoms)
- •previous pulpal treatment on the tooth
- •necrotic pulp
- •hyperemic pulp
- •inadequate operative technique, defective restauration
- •non diagnostic x-ray (pre or post treatment)
研究组 & 干预措施
Formocresol/OZE
Active Comparator
Conventional pulpotomy technique, with formocresol and zinc oxide eugenol
干预措施: Pulpotomies with Formocresol/OZE and Biodentine (Procedure)
Biodentine
Active Comparator
New technique, with biodentine
干预措施: Pulpotomies with Formocresol/OZE and Biodentine (Procedure)
结局指标
主要结局
clinical success
时间窗: 12 months post treatment
radiographic success
时间窗: 12 months post treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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