Evaluation of the Anti-anaesthetic Effects of Low-Level Laser Therapy on Children's Soft Tissue Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Outcomes measuring the duration (in minutes) of anaesthesia withdrawal after laser application
研究概览
简要总结
Evaluate the effect of the photobiomodulation mode of the diode laser on the anaesthetic area and find the best parameter that would accelerate the withdrawal of anaesthesia.
详细描述
A randomized clinical trial will be performed at the Pedodontics Out Paediatric Clinic at the Facility of Dental Medical for girls. Al Azhar University has twenty patients with upper or lower first primary molars on the right and left sides that need to be treated. Using the split-mouth technique, the mouth will be split in two halves. The first half represents the first group, and the second half represents the second group.
Group I (20 teeth): the anaesthesia will be reversed by the photobiomodulation mode of diode laser (low-level laser therapy).
Group II (controlled group): 20 teeth of anesthesia will be withdrawn without intervention.
To avoid bias in the 2nd group, the laser will be applied on this side, but in turned-off mode. The type of anaesthesia that will be evaluated is articine hydrochloride 4% with 1:200 epinephrine (vasoconstrictor).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Parents have to complete the written consent form. Patient who behaved well. Children aged from 6 to 12 years can evaluate soft tissue anaesthesia. Patients that require treatment with bilateral upper or lower first primary molar infiltration under anaesthesia.
排除标准
- •Patients who are mentally disordered or hand-capped. uncooperative patients.
结局指标
主要结局
Outcomes measuring the duration (in minutes) of anaesthesia withdrawal after laser application
时间窗: after application of laser immediately and continue each 15 minutes till complete withdrawal of anaesthesia
1. Return the normal sensation to the lip. 2. Being able to smile, drink, and talk normally. 3. Return of pain sensation that result from the procedure
次要结局
未报告次要终点
研究者
Alaa M Eldehna
lecturer of paediatric dentistry
Al-Azhar University