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临床试验/CTRI/2025/03/083403
CTRI/2025/03/083403尚未招募不适用

Evaluation of Surface Topographic Changes In Single System Pediatric Rotary Files Following Repeated Use - A Randomized Clinical Trial

Dr Bhuvaneswari Natarajan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月31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
30
试验地点
1
主要终点
Surface topographic changes

研究概览

简要总结

This study aims to assess the surface topographic changes in single-system pediatric rotary files after multiple uses in primary teeth using stereomicroscope. A randomized clinical trial will be conducted on extracted primary teeth requiring pulpectomy. Pediatric rotary files will be used for root canal preparation and categorized based on the number of uses (e.g., new, after 3 uses, after 5 uses). Surface characteristics will be evaluated using stereomicroscope to detect wear, deformation, or micro-fractures. Data will be statistically analyzed to determine the impact of repeated use on file integrity. The study aims to provide insights into the safe usage limits of pediatric rotary files, ensuring effective and safe endodontic treatment in children while minimizing instrument failure risks. Findings will guide clinicians on the longevity and safety of pediatric rotary files, optimizing their clinical application and enhancing patient safety.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
5.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Teeth indicative of pulpectomy and primary molars with only three roots.

排除标准

  • Primary anterior teeth and primary molars with more than three roots.

结局指标

主要结局

Surface topographic changes

时间窗: at baseline,3rd use,5th use,9th use,12th use and 15th use of the file.

次要结局

  • Cutting efficiency of the file(At baseline,3rd use,5th use,9th use,12th use & 15th use of the file.)

研究者

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

Dr Vignesh Ravindran

saveetha dental college and hospital

研究点 (1)

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