NCT04061265已完成1 期
Articaine Efficacy and Safety in Young Children Below Age of Four Years: An Equivalent Parallel Randomized Control Trial
Minia University2 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2019年8月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Pain assessment
研究概览
简要总结
Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 37 Months 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.
排除标准
- •The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness
结局指标
主要结局
Pain assessment
时间窗: During the procedures
FLACC scale
Behavior
时间窗: before and after the procedures
Frankl behaviour scale
次要结局
- postoperative complications(24 hours after the procedures)
研究者
Ahmad Elheeny
Lecturer of Pediatri, Faculty of Dentistry, Minia University
Minia University
研究点 (2)
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