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临床试验/CTRI/2024/06/069096
CTRI/2024/06/069096尚未招募4 期

Comparative evaluation of clinical effectiveness of two indigenous papain based chemomechanical caries removal agents – A randomized controlled trial

Dr Shyam Sivasamy1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月17日最近更新:

试验速览

阶段
4 期
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 clinical effectiveness of two indigenous

研究概览

简要总结

Patients of the required eligibility  criteria will be selected and participants will be randomized and will be grouped into intervention and control groups and the outcomes will be assessed at the end of 3,6,9 and 12 months

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

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

入选标准

  • Children with bilateral carious lesions not extending beyond the inner one third of dentin in radiograph Children of parents who give consent for participation in the study Children who give assent.

排除标准

  • Children who have multiple deep caries lesions which require pulp therapy or treatment under general anesthesia Children with special needs.

结局指标

主要结局

To compare the clinical effectiveness of two indigenous

时间窗: baseline , 3 months, 6 months,9 months and 12 months

papain based chemomechanical caries removal agents

时间窗: baseline , 3 months, 6 months,9 months and 12 months

among Children

时间窗: baseline , 3 months, 6 months,9 months and 12 months

次要结局

  • Survival rates of restorative material placed after caries removal(Incidence of secondary caries)

研究者

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

Dr Lakshmi Priya

Meenakshi Ammal Dental College and Hospital

研究点 (1)

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