Comparative Evaluation of Pain Perception With a New Needle-Free System and Dental Injection in Children: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Pain at different anesthesia methods
研究概览
简要总结
The purpose of this study is to evaluate and compare the pain perception associated with a needle-free injection system( Comfort-In) and dental injection method in filling and pulpotomy treatments
详细描述
Needle-free injection system(Comfort-In) and dental injection method was applied on the teeth of children who need dental treatment.70 patients were included in the study. Patients were randomized into two grups according to the injection technique.
Group1: Needle-free injection system(Comofrt-In) 2:Dental injection method. The pain intensity was assessed during anesthesia, during treatment and at the end of thetreatment by the Wong Baker Faces Pain Scale.
The datas were analyzed with a three-way variance method in repeated.
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
- None
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 4-11 years
- •Having no developmental or systemic disorder or no history of allergy
- •Having "positive" or "definitely positive" cooperation level according to the Frankl Behavior Scale
- •Having sufficient mouth opening
- •Operation only on primary teeth
- •Having decayed teeth that require anesthesia
排除标准
- •Patients younger than five years, older than 11 years,
- •Patients with systemic or developmental disorders
- •Children with an allergy history
- •'Negative' or 'definitly negative' behavior rating according to the Frankl scale
- •Patients whose mouth opening is not sufficient for dental treatment
- •Operating only on permanent teeth
- •Teeth that are beyond the treatment stage
- •When pain occurred during treatment, supplemental anesthetics administrated, and these children were excluded.
结局指标
主要结局
Pain at different anesthesia methods
时间窗: after dental treatments to 24 hour
The pain perception scores in the two anesthesia methods were assessed with Wong-Baker Pain Scale (Wong-Baker Scale is pain assessment method.It consists of 6 facial expressions that are evaluated from 0 to 10 according to the severity of the pain.)
次要结局
未报告次要终点
研究者
Halenur Altan
Associated Professor
Tokat Gaziosmanpasa University