Potential ramifications of counterfeits, replicas in endodontic practice

Investigators have systematically mapped laboratory evidence on the performance of counterfeit and replica-like Ni-Ti endodontic files.

In a scoping review published in the Australian Dental Journal, the investigators used the data from 17 in vitro studies to analyze the properties and mechanical performance of counterfeit and replica-like nickel-titanium endodontic files.

While counterfeit and replica-like endodontic files may appear identical to authentic endodontic instruments, the investigators found a range of deviations from standards in quality control, metallurgy, design and performance. For instance, they noted design irregularities, surface finishing defects and alterations in metallurgic characteristics among the counterfeit endodontic files that resulted in declines in cyclic fatigue resistance and stable mechanical behavior. Although some replica-like endodontic files were comparable to authentic instruments, they exhibited variable performance and at times inferior flexibility or torsional resistance compared with the authentic instruments. The investigators argued that the flaws they uncovered in their review of counterfeit and replica-like endodontic files could result in instrument and treatment failure.

The findings demonstrated that endodontic files that aren’t authentic could come with quality manufacturing and performance issues that could compromise mechanical reliability and patient safety. The investigators stressed that greater regulatory measures and clinical assessments are needed to ensure that clinicians can select the proper instruments and to establish guidance for the responsible use of comparable replica-like endodontic files.

Read more: Australian Dental Journal

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