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临床试验/CTRI/2025/10/095680
CTRI/2025/10/095680尚未招募不适用

Postoperative recovery with low-level laser therapy in reversing the anesthetic effect of 4 percent articaine: a randomized clinical trial

Peoples College of Dental Sciences and Research Center Bhopal1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月2日最近更新:

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

发起方
Peoples College of Dental Sciences and Research Center Bhopal
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Rohit khairnar

Peoples College of Dental Sciences and Research Center

研究点 (1)

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