A Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- scale of pain perception by Sounds, eyes, and motor (SEM) scale.
研究概览
简要总结
This study was conducted to a Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems.
详细描述
The study evaluates and compares pain perception of the inferior alveolar nerve block (IANB) and buccal infiltration anaesthetic in children using a Conventional syringe, STA Single Tooth Anesthesia® System and Star Pen anaesthesia device.
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
- None
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy children (5-8) years old, and free from systemic diseases.
- •Children who require local anesthetic injection for any dental treatment.
- •Cooperative children (positive or definitely positive on Frankel's scale).
- •Children who have no contraindications to the usage of selected local anesthetic agents.
排除标准
- •All that does not correspond to inclusion criteria.
研究组 & 干预措施
Group I: Control Group
Use a conventional syringe to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a conventional syringe to inject anesthetic solution by buccal infiltration (BI) technique.
干预措施: STA Single Tooth Anesthesia® System. (Device)
Group I: Control Group
Use a conventional syringe to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a conventional syringe to inject anesthetic solution by buccal infiltration (BI) technique.
干预措施: Star Pen anesthesia device. (Device)
Group II: STA group
Use STA Wand® (CCLA) to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use STA Wand® (CCLA) to inject anesthetic solution by buccal infiltration (BI) technique.
干预措施: Conventional Syringe (Device)
Group II: STA group
Use STA Wand® (CCLA) to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use STA Wand® (CCLA) to inject anesthetic solution by buccal infiltration (BI) technique.
干预措施: Star Pen anesthesia device. (Device)
Group III: Star pen group
Use a Star Pen device to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a Star Pen device to inject anesthetic solution by buccal infiltration (BI) technique.
干预措施: Conventional Syringe (Device)
Group III: Star pen group
Use a Star Pen device to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a Star Pen device to inject anesthetic solution by buccal infiltration (BI) technique.
干预措施: STA Single Tooth Anesthesia® System. (Device)
结局指标
主要结局
scale of pain perception by Sounds, eyes, and motor (SEM) scale.
时间窗: Up to 12 weeks.
The primary outcome was evaluated using Sounds, eyes, and motor (SEM) scale. These responses are categorized on a scale ranging from 1-4 categories comfort, mild discomfort, moderately painful, and painful. Two pediatric dentists who are blind to injection devises will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two.
scale of pain perception by Wong-Baker FACES Pain Rating scale
时间窗: Up to 12 weeks.
The primary outcome was evaluated using Wong-Baker FACES Pain Rating scale. The child was briefly explained about each face and then asked to select the face that best described their feelings during the administration of local anesthesia. The scale consists of 6 cartoon faces depicting varying facial expressions, ranging from a very happy face (score 0) to a very sad one (score 10).
次要结局
未报告次要终点
研究者
Osamah Mohammed Abdulghani Almekhlafi
Principal Investigator
Mansoura University