跳至主要内容
临床试验/CTRI/2024/06/068314
CTRI/2024/06/068314招募中4 期

Evaluating the disinfection effectiveness of two different irrigation needles in primary teeth – A Randomized Controlled Trial

AIIMS Rajkot1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
64
试验地点
1
主要终点
Reduction in the bacterial count

研究概览

简要总结

Children in the age group of 6-9 years with necrotic primary molars that are indicated for pulpectomy will be included in the trial. The inclusion of participants will be done randomly and every effort will be made to reduce the operator and selection bias while conducting the trial. After getting the informed consent from the parents of the participants, pulpectomy will be initiated under proper isolation of the operating field. Irrigation with an antibacterial solution will be done using either open-ended or side-vented needles as per the randomization code. Bacterial samples will be collected from the root canals before and after irrigation. The collected samples will be transferred for evaluation of bacterial reduction.

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
6.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Children belong to positive or definitely positive classes of the Frankel behavior rating scale.
  • Children in the age group of 6 – 9 years.
  • Children with necrotic primary molars with adequate crown structure for post-endodontic restoration.
  • Children with decayed primary molars with sinus opening Children with decayed primary molars with furcation radiolucency Children with decayed primary molars with minimal or no resorption.

排除标准

  • Specially challenged children Children with Negative/Definitely Negative classes of the Frankel behavior rating scale.
  • Children under analgesics or antibiotics 12 hours before the treatment schedule.

结局指标

主要结局

Reduction in the bacterial count

时间窗: 1st day

次要结局

  • Post-operative pain(6 hours, 24 hours, and 7 days)

研究者

发起方
AIIMS Rajkot
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Patnana Arun Kumar

AIIMS Rajkot

研究点 (1)

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