a Spilt Mouth Clinical Comparative Evaluation of the Electronic Anesthetic Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Onset time
研究概览
简要总结
A Spilt Mouth Clinical Comparative Evaluation Of The Electronic Anesthetic Efficacy Comparison of traditional local anesthesia with electronic local anesthesia in terms of the ability to reduce pain during injection and the duration of the anesthetic effect
详细描述
Study Design:
The mouth will be split in half using a split mouth study. The lower anterior teeth will be injected with a conventional local anesthetic syringe on one side, and the patient will be injected with an electronic anesthetic syringe on the other side.
The study will be conducted on a sample of volunteers aged 18 to 30 years at the Faculty of Dentistry at Al-Andalus University.
The objectives and procedure will be explained to each group of patients, and informed consent will be obtained from each patient to accept the research procedures.
A 2% non-vasoconstrictor lidocaine local anesthetic will be used for all patients.
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
- Double (Care Provider, Investigator)
盲法说明
single blinded
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •". Age ranged from 20 to 30 years , no menstrual cycle, The participants were not allergic to local anesthetics, had not used medication that would alter pain perception, none of them had not ever experienced Smartject injection before, and none of them were alcoholics or smokers, The participants were not allergic to local anesthetics.
排除标准
- •allergic to local anesthetics ,females during menstural cycle ,bad oral care.
结局指标
主要结局
Onset time
时间窗: 2 month
was considered as the period between the end of the injection and the first subsequent Onset time was considered as the period between the end of the injection and the first subsequent readings without response. After this period, the tooth was tested every 10 minutes until readings returned to the baseline threshold. Each subject was asked to record the time of return to normal sensation in the lower lip
次要结局
- Visual Analogue Scale (VAS)(2 month)
研究者
Mouetaz Kheirallah
Ph.D., OMFS, DDS, Associate Professor
Arab University for Science and Technology