Pain Perception of Maxillary Infiltration Injection of Dental Local Anesthesia Using "DentalVibe Comfort System" Compared to Maxillary Infiltration Injection Alone in a Group of Egyptian Children: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 21
- 主要终点
- pain during injection
研究概览
简要总结
The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone in pediatric dental patients.
详细描述
The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone.
Intervention:
History taking from the child and the parent including personal, medical and dental history as in the examination sheet (Appendix A) to assess inclusion criteria.
Clinical procedure:
Intervention group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 6-7 years old.
- •Apparently healthy Children.
- •Cooperative children.
- •Children with carious maxillary bilateral primary molars indicated for extraction.
排除标准
- •Children who are allergic to amide group.
- •Children with Neurologic disorders.
- •Children with mental disability.
- •Presence of periapical or gingival legion.
- •Severe Gingivitis.
结局指标
主要结局
pain during injection
时间窗: within 1 year
pain assessment using FLACC behavioral pain assessment (scale 0-10) and Wong-Baker FACES pain rating scale (scale 0-10) e 0: Relaxed and comfortable 1-3: Mild discomfort. 4-6: Moderate pain. 7-10: Severe discomfort or pain or both.
次要结局
未报告次要终点
研究者
Muaaz Marwan halal
principal investigator
Cairo University