Postoperative recovery with low-level laser therapy in reversing the anesthetic effect of 4 percent articaine: a randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- there should be reduction in duration of anesthetic effect after laser application
研究概览
简要总结
METHODOLOGY-
A randomized clinical trial will be conducted on sample size of 60 children with age group of 5-8 years undergoing dental procedures which requires local anaesthesia administration.
Patients included in the study will be divided randomly into two groups according to use of postoperative LASER to nullify the effect of 4% Articaine.
Group A: Local anesthesia with 4% articaine and the use of a diode laser for the reversal of its effect.
Group B: Local anesthesia with 4% articaine without the use of a diode laser for the reversal of its effect.
Procedure: -
Patients will be advised to take an analgesic before treatment to prevent pain once the anaesthetic effect wears off.
All patients will first receive a nerve block with local anesthesia (4% Articaine). Half a cartridge will be administered to patients weighing between 15 kg to 30 kg, while a full cartridge (1.7 ml) will be given to children weighing more than 30 kg.
The dental procedure will be performed following a standardized protocol in 40 minutes.
Group A will be the experimental group, where LASER will be used for the reversal of anesthesia, and the patient will be monitored until he/she regains sensation.
Group B will be the control group, where LASER will not be used for the reversal of anesthesia, and the patient will be monitored until he/she regains sensation.
Regaining of sensation will be check by
a)Lip taping: Every 10 min for 2 hr after exposure or until the patient senses the lip tapping.
b)Two-point discrimination: Comparison between normal side with anaesthetic side.
c)Current Perception Threshold: A painless transcutaneous electro-diagnostic sensory threshold test of the peripheral nervous system using TENS. An electric stimulus will be administered at a frequency of 5 Hz. The current intensity will be controlled via an adjustable regulator switch with a range of 0-10 until a shock sensation is felt by the child.
d)Paediatric Function Assessment Battery: The child will be assessed for functional impairments such as dysphagia (evaluated by drinking 90 ml of water), dysarthria (assessed by saying ten words), dysphonia (checked by grinning broadly), and nausea.
e)Soft tissue injury assessments: Soft tissue injury assessment will be conducted through a 24-hour follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Double
入排标准
- 年龄范围
- 5.00 Year(s) 至 8.00 Year(s)(—)
- 性别
- All
入选标准
- •Children undergoing dental procedure which requires local anesthesia.
- •Children with no relevant medical history.
- •Frankel behavior score of 3 and 4.
排除标准
- •Children with previous history of photosensitivity.
- •Children with systemic diseases and illness (with pacemaker or any other electromagnetic devices).
- •Frankel behavior score of 1 and 2.
结局指标
主要结局
there should be reduction in duration of anesthetic effect after laser application
时间窗: every 10-15 min
次要结局
未报告次要终点
研究者
Dr Rohit khairnar
Peoples College of Dental Sciences and Research Center
