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临床试验/CTRI/2025/04/085417
CTRI/2025/04/085417尚未招募2/3 期

Comparative evaluation of a balloon vine leaf extract gel and 2 percentage lignocaine gel as an intraoral topical anaesthetic agent in children of 6-10years: a randomized controlled trail.

Dr Sahana S1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To compare & evaluate the pain perception

研究概览

简要总结

Pain and fear of dental injection in children can be a significant concern, impacting their overall dental experience and oral health. The current study aims to compare and evaluate the pain perception following topical application of balloon vine leaf extract gel and lignocaine gel prior to intra oral injections in children.

Methods:

This was randomised, controlled and triple blinded study. 30 children aged 6-10 years requiring administration of Local anesthesia were included in the study. Each sample was again divided into two groups, Group I (n=15) Balloon vine leaf extract gel, Group II (n=15) lignocaine gel were applied as Pre anaesthetic agents followed by administration of Local anesthesia.

Pulse oximeter was used to assess the anxiety levels before, during and after LA administration. Pain perception for needle insertion was analysed subjectively by Memoji’s Pain Scale and objectively by Sound, Eye, Motor, (SEM)scale. All the recorded data were tabulated and statistically analysed by Paired t-test(P<0.05).

研究设计

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

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children with good general health, Frankel Behaviour rating of 3 and 4, requiring administration of local anesthesia, willing to participate with parents consent are included.

排除标准

  • Medically compromised children, children with active pathosis in the injection region and any history of allergy to Local Anaesthesia are excluded from the study.

结局指标

主要结局

To compare &amp; evaluate the pain perception

时间窗: 1 min after application

following topical application of balloon vine leaf extract gel &amp; commercially 2% ligocaine gel

时间窗: 1 min after application

次要结局

  • To evaluate any adverse effects following their application(10mins after application)

研究者

发起方
Dr Sahana S
申办方类型
Other [[self]]
责任方
Principal Investigator
主要研究者

Dr Sahana S

AME S dental college and hospital, bijangera, raichur, karnataka

研究点 (1)

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