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临床试验/CTRI/2024/07/071298
CTRI/2024/07/071298尚未招募不适用

COMPARISON OF TOPICAL APPLICATION OF ICE VERSUS 2PERCENT LIGNOCAINE GEL IN REDUCING ORAL MUCOSAL INJECTION PAIN A SPLIT MOUTH STUDY

KVG dental college and hospital, Sullia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月15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
20
试验地点
1
主要终点
To compare the efficiency of topical ice application and 2% lignocaine gel in reducing oral

研究概览

简要总结

This study aims to compare the efficacy of topical ice application versus 2% lignocaine gel in reducing oral mucosal pain during buccal and palatal injections for bilateral extraction of maxillary premolars. The primary objective is to evaluate pain intensity using the Visual Analogue Scale (VAS) after each method of anesthesia administration. Additionally, heart rate changes during injections will be assessed using a digital pulse oximeter. The study hypothesizes that topical ice is as effective as lignocaine gel in reducing injection pain.

Twenty patients aged 18-30 years, meeting inclusion criteria and without exclusion criteria, will participate in this randomized controlled split-mouth clinical trial at KVG Dental College & Hospital. Each patient will receive both forms of anesthesia (ice application and lignocaine gel) during separate extraction sessions, randomly assigned to either side of the mouth.

Procedure involves topical anesthesia application using standardized techniques. Pain assessment will be immediate post-injection using the VAS, where a score of 0 indicates no pain and 10 indicates severe pain. Heart rate variations will be monitored throughout the procedure.

This study contributes to understanding the comparative effectiveness of topical ice versus lignocaine gel in dental anesthesia, potentially influencing clinical practice guidelines to optimize patient comfort and procedural outcomes.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Patients who are willing to participate in the study.
  • Patients indicated for bilateral maxillary premolar teeth extraction.
  • Male and female patients of age 18-30 years.-Individuals under ASA I and II.

排除标准

  • Reported allergy or hypersensitivity to sulphites, amide type local anesthetics, ingredients in anesthetic solution or any of the products used in the study.
  • Patients with severe acute infections.
  • Patients with gross periapical pathology.
  • Patients having a habit of smoking and consuming alcohol.
  • Women who are pregnant.

结局指标

主要结局

To compare the efficiency of topical ice application and 2% lignocaine gel in reducing oral

时间窗: heart rate pre op and post op | 1.5mins after ice and LA gel application- VAS scale

mucosal pain

时间窗: heart rate pre op and post op | 1.5mins after ice and LA gel application- VAS scale

次要结局

  • 1. To assess the pain during buccal palatal injection after ice application based on Visual(Analogue Scale.)

研究者

发起方
KVG dental college and hospital, Sullia
申办方类型
Other [Private dental college and hospital]
责任方
Principal Investigator
主要研究者

Dr Sweta V Giddappanavar

KVG Dental college and hospital, Sullia

研究点 (1)

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