Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain on Puncture (PoP)
研究概览
简要总结
This single-blind two-arm randomized control trial (RCT) aims to evaluate the pain perception during and following administration of dental local anaesthesia using two different systems; i.e. computer-controlled (CCLA) and conventional.
详细描述
The administration of local anaesthesia (LA) is associated with pain, fear and anxiety. Computer-controlled LA (CCLA) aims to control the administration speed and reduce pain, fear and anxiety. This randomised control trial (RCT) aims to compare the pain perception after CCLA and conventional LA, and it uses dental students as both test and operator group versus an experienced dentist as an additional operator of the LA.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dental students at the Faculty of Medicine, University of Giessen enrolled in the course of Local Anaesthesia.
排除标准
- 未提供
结局指标
主要结局
Pain on Puncture (PoP)
时间窗: Within 2 hours
Self-reported pain intensity on puncture using visual analogue scale (0 = no pain- 10 = the worse pain)
Pain during Delivery (PdD)
时间窗: Within 2 hours
Self-reported pain intensity during delivery of the anaesthetic solution sing visual analogue scale (0 = no pain- 10 = the worse pain)
次要结局
- Dental Anxiety (DA)(Within 2 hours)
研究者
Sameh Attia
Head of the Dental Polyclinic
University of Giessen