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临床试验/CTRI/2024/06/069107
CTRI/2024/06/069107尚未招募不适用

To compare the effectiveness of laser bio stimulation (LBS), ice popsicle and anesthetic gel in reduction of local anesthesia injection pain in children

DrHarshita Gosavi1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年6月20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
90
试验地点
1
主要终点
1. Ice popsicle is as effective as local anesthetic gel to reduce pain and discomfort prior to injection

研究概览

简要总结

Title: Effectiveness of laser biostimulation , ice popsicle and anesthetic gel in reduction of local anesthesia injection pain in children

Aim: To compare the effectiveness of laser bio stimulation (LBS), ice popsicle, and LA gel in reducing pain during administration of LA injection in children aged 9-12 years.

Objectives:

1.     To evaluate efficacy of ice popsicle in reducing pain during administration of LA injection

2.     To evaluate efficacy of laser biostimulation in reducing pain during administration of LA injection

3.     To compare the effectiveness of laser bio stimulation (LBS), combination of cryotherapy and sugar, and LA gel in reducing pain during administration of LA injection

Material and Methods:

This is a randomized controlled double-blind study that will be carried out on children aged 9-12 years reporting to outpatient Department of Pediatric and Preventive Dentistry, RUHS College of Dental Sciences, Jaipur after approval from the ethical committee and prior consent from the parents.

Patients will be randomly divided into 3 groups:

Group A: LA gel application

Group B: Ice popsicle application

Group C: Laser bio stimulation

The assessments of pain response were carried out during the administration of local anesthesia using Wong-Baker Faces Pain Rating Scale and Sound Eyes Motor scale (SEM), respectively.

Inclusion criteria:

Children aged 9-12 years of either gender requiring palatal anesthesia

Cooperative children with Frankl behaviour rating scale- III or IV

Exclusion criteria:

Uncooperative children (Frankl behavior I and II)

Any history of abscess, redness at the injection site.

Patients not willing to participate in the study

Groups:

Group A: 2% Local anesthetic gel

Group B: Ice popsicle

Group C; Laser Photobiostimulation

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
9.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children aged 9-12 years of either gender requiring palatal infiltration
  • Cooperative children with Frankl Behavior rating 3 or 4.

排除标准

  • Uncooperative children ( Frankl behaviour rating 1 or 2)
  • Any history of abscess or redness at injection site
  • Patients not willing to participate in the study.

结局指标

主要结局

1. Ice popsicle is as effective as local anesthetic gel to reduce pain and discomfort prior to injection

时间窗: Immediately post operatively

2. Laser biostimulation is as effective as local anesthetic gel to reduce pain and discomfort prior to injection.

时间窗: Immediately post operatively

次要结局

  • Ice popsicle and Laser Biostimulation can be used to reduce pain and discomfort and can be an alternative to topical anesethetic(Post operatively)

研究者

发起方
DrHarshita Gosavi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Harshita Gosavi

RUHS College of Dental Sciences,Jaipur

研究点 (1)

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