Comparision of Injection Pain Caused by the 'Comfort in' Injection System Versus a Traditional Syringe for Inferior Alveolar Nerve Block Anaesthesia in Primary Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Wong-Baker Faces Pain Rating Scale (PRS)
研究概览
简要总结
The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In need of treatment of right and left molar teeth of mandible,
- •Does not have any systemic disorder,
- •High level of communication that can provide logical answers to the questions we ask
- •With parental consent,
- •Volunteers who want to participate in the research
- •6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic
排除标准
- •No need for treatment of right and left molar teeth of mandible,
- •Has a systemic condition
- •Low level of communication that cannot provide reasonable answers to the questions we ask
- •Without parental consent
- •Do not want to participate voluntarily in the research
- •Do not attend a check-in
- •Patients not in the 6-12 age group
研究组 & 干预措施
experimental
local anesthesia applyed with Comfort in system
干预措施: Comfort-in injection system (Device)
conventional injection
local anesthesia applyed with conventional syringe
干预措施: conventional injection with dental needle (Other)
结局指标
主要结局
Wong-Baker Faces Pain Rating Scale (PRS)
时间窗: 1 year
The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, "no hurt") to 5 (crying/screaming face, "hurts worst").
Face, Legg, Cry, Consolability Scale (FLACC)
时间窗: 1 year
The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain \[Willis et al., 2003\]. Behavioural parameters were recorded.
次要结局
未报告次要终点
研究者
Sinem yildirim
Assistant Professor
Okan University