跳至主要内容
临床试验/CTRI/2025/06/089676
CTRI/2025/06/089676已完成不适用

Comparative Evaluation of Atricaine and Lidocaine Hydrogels for Pain Management in Deep Carious Lesions in Children: A Randomized Controlled Trial

Ashish Suresh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月8日

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Pain perception using VAS and Wong Baker scale

研究概览

简要总结

This randomized controlled trial evaluated the effectiveness of Atricaine hydrogel versus Lidocaine hydrogel for pain control during the treatment of deep cavities in children aged 5–10 years. The study involved three groups (Atricaine, Lidocaine, and a control) and measured pain levels using standardized scales (e.g., FLACC or Wong-Baker FACES). Results indicated whether Atricaine provided superior, equivalent, or inferior anesthesia compared to Lidocaine, with implications for clinical practice in pediatric dentistry. The sample size was calculated to ensure statistical power, accounting for potential dropouts. Findings aim to guide dentists in choosing the most effective and child-friendly topical anesthetic for managing discomfort during caries treatment.

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
5.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient reporting to the dental operatory for the first time to minimize behavioural bias 2.Patients from the age group 5 to 10 3.Children not requiring pulp therapy procedures 4.Individuals without any cognitive or systemic disabilities.

排除标准

  • 1.Children with prior dental experience 2.Patients with developmental or linguistic disorders who cannot communicate properly 3.Children with medications which affect behaviour 4.Medically and systematically compromised patients 5.Patients with cognitive impairments or special needs.

结局指标

主要结局

Pain perception using VAS and Wong Baker scale

时间窗: At baseline

次要结局

  • The start of the action, duration of postoperative analgesia, & occurrence of any problems. The duration of(anesthesia was assessed by the feeling of numbness & the first sign of pain.)

研究者

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

Ashish Suresh

Saveetha Dental College and Hospitals

研究点 (1)

Loading locations...

相似试验