The Efficiacy Of Dental Electronic Syringe In Reducing Disconfort During Local Infiltration Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Heart rate variability
研究概览
简要总结
The goal of this clinical study is to compare patients' self-reported pain and mental stress during infiltration anesthesia between conventional syringe and Dentapen.
Outcome 1: VAS score of self-reported pain during dental anesthesia Outcome 2: Heart rate variability during dental anesthesia
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
- Single (Participant)
盲法说明
Participants were covered their face with a drape for masking the instrument was using.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •absence of cardiovascular disease
- •tooth extraction indication of orthodontist
- •no allgergy with any medications used in this study
- •bilaterally symmetrical maxillary premolars
- •the extracted promolars are in the same clinical condition
排除标准
- •has been diagnosed with any mental diseases
- •pregnancy patient
- •individuals with alcohol or subtance use disorder
- •local inflammation at injection site
研究组 & 干预措施
Dentapen
On the experimental side, researcher used Dentapen, a Computer-Controlled Local Anaesthetic Delivery device, to deliver anesthesia for patients.
干预措施: computer controlled local anesthesia delivery device (Dentapen) (Device)
Control
This arm was admistered local anesthesia with conventional syringe
干预措施: Control (Device)
结局指标
主要结局
Heart rate variability
时间窗: From enrollment to the end of tooth extraction treatment at 4 weeks. Each patient experienced two extraction treatments with 4-week interval.
Heart rate variability (HRV) is is the precise measure of the variation in time (milliseconds) between consecutive heartbeats. HRV is measured using a device around patient chest.
Self-reported pain
时间窗: Patients reported right after dental anesthesia delivery.
Patients reported how much pain intensity that they feel during dental anesthesia by using a visual analogue scale. Scale value ranges from 0 (no pain) to 100 (maximum pain).
次要结局
未报告次要终点
研究者
Son Hoang Le
Lecturer
University of Medicine and Pharmacy at Ho Chi Minh City