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对正品和假冒伪劣旋转镍钛根管器械的物理和制造性能的批判性评估。

A critical evaluation of physical and manufacturing properties of genuine and counterfeit rotary nickel-titanium endodontic instruments.

机构信息

Melbourne Dental School, The University of Melbourne, Melbourne, Australia.

出版信息

Aust Dent J. 2023 Sep;68(3):179-185. doi: 10.1111/adj.12964. Epub 2023 Jun 20.

DOI:10.1111/adj.12964
PMID:37337920
Abstract

BACKGROUND

Rotary nickel-titanium (NiTi) instruments are made to exacting standards and are costly to manufacture, and quality control is paramount. Consequently, unauthorized factories make counterfeit instruments that are less expensive and may therefore be attractive to dentists. Little information exists about the metallurgy and manufacturing quality of such instruments. There is the potential for counterfeit instruments to be at higher risk of fracture during treatment, thereby compromising clinical outcomes. The aim of this study was to evaluate physical and manufacturing properties of genuine and counterfeit ProTaper Next™ and Mtwo® rotary NiTi instruments.

METHODS

This study investigated the metallurgical properties, manufacturing quality, microhardness and number of cycles to failure of two commonly used rotary NiTi systems and compared them with counterfeit products purporting to be genuine articles.

RESULTS

Counterfeit instruments were found to be inferior in manufacturing standards and were less resistant to cyclic fatigue when compared to genuine instruments.

CONCLUSIONS

Counterfeit rotary NiTi instruments may be less efficient at preparing root canals and may be at higher risk of fracture during endodontic treatment. Dentists must be aware that, although less expensive, counterfeit instruments may be of dubious manufacturing quality and at higher risk of fracture if used in patients. © 2023 Australian Dental Association.

摘要

背景

旋转镍钛(NiTi)器械的制造标准非常严格,制造成本也很高,因此质量控制至关重要。于是,一些未经授权的工厂生产假冒器械,这些器械价格更低廉,可能对牙医更具吸引力。关于这些器械的冶金学和制造质量的信息很少。假冒器械在治疗过程中更有可能出现断裂,从而影响临床效果。本研究的目的是评估 ProTaper Next™和 Mtwo®两种常用旋转镍钛器械的真实和假冒产品的物理和制造性能。

方法

本研究调查了两种常用的旋转镍钛系统的冶金性能、制造质量、显微硬度和失效循环次数,并将其与声称是正品的假冒产品进行了比较。

结果

与正品器械相比,假冒器械的制造标准较低,耐循环疲劳性较差。

结论

与正品器械相比,假冒的旋转镍钛器械在预备根管时效率可能较低,在牙髓治疗过程中发生断裂的风险可能更高。牙医必须意识到,尽管价格较低,但假冒器械的制造质量可能存在疑问,如果在患者身上使用,断裂的风险可能更高。© 2023 澳大利亚牙科协会。

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