跳至主要内容
临床试验/CTRI/2023/07/055656
CTRI/2023/07/055656尚未招募不适用

Comparative evaluation of cryotherapy, low level laser therapy and vibrating device for alleviating pain and anxiety during administration of local anesthesia using salivary cortisol levels: An Elisa based study

Anusha dixit1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年8月30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
80
试验地点
1
主要终点
Effective pain control in children lays the foundation of successful behaviour management and hence the treatment. Thus, eliminating fear and anxiety of injections is of paramount importance in pediatric dentistry.

研究概览

简要总结

The aim of the study is tocompare and evaluate the efficacy of topical anesthesia, Cryotherapy, Vibratingdevice & Low-level laser therapy on alleviating pain and anxiety duringadministration of Local Anesthesia.Informed consent will be obtained fromeach subject’s parents before enrolling them in study. For each participant, atleast one parent/guardian will be informed about the procedure and will beasked to sign the consent form. 80 subjects requiring any dental procedure will be selected and randomly assigned to one of the four groups. The four groups will be topical anesthesia, cryotherapy, low level laser therapy and vibrating device .Effectivepain control in children lays the foundation of successful behaviour managementand hence the treatment. Thus, eliminating fear and anxiety of injections is ofparamount importance in pediatricdentistry.0s

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

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 who require inferior alveolar nerve block 2.Five to Eight years old healthy children.
  • Frankl’s Behaviour rating scales III and IV.

排除标准

  • No aversive experience about medical or dental treatment.
  • Children with allergy to local anaesthesia.
  • Children with systemic diseases, intellectual disability, psychiatric disorders and dental abscesses or fistulas in the procedure site.

结局指标

主要结局

Effective pain control in children lays the foundation of successful behaviour management and hence the treatment. Thus, eliminating fear and anxiety of injections is of paramount importance in pediatric dentistry.

时间窗: 24hrs

次要结局

  • Topical Anesthesia, Cryotherapy, Vibrating device & Low-level laser therapy will be effective in reducing pain and anxiety during local anesthesia administration in children with or without statistical significant difference.

研究者

发起方
Anusha dixit
申办方类型
Other [self]

研究点 (1)

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