Counterfeit Endodontic Files Features Objectified with Scanning Electronic Microscopy: Comparative Study of SOCO SC Pro Original and Falsified Rotary Instruments

Abstract

Objective of the research was to compare SEM characteristics of original and counterfeit SOCO SC Plus endodontic files and systematize features, which potentially may be used as markers for the falsified rotary instruments identification. 45 original SOCO SC Pro endodontic files (SCor group) and 45 SOCO SC Pro counterfeit files (SCcf group) were used for the scanning electronic microscopy analysis. Each group of files was analyzed with obtaining following set of scanning electron microscopy images: the general view of the working part, the view of the instrument’s working tip, the view of the surface and the side face, the view of the fixation area in the projection of the shank. Group of SOCO SC Plus counterfeit files demonstrated statistically higher prevalence of scrapings (p < 0.05) and cracks (p < 0.05) compared to the group of SOCO SC Plus original instruments. Counterfeit SOCO SC Plus files demonstrated greater diameter of the working tip’s base, sharper tip’s design and presence of compound’s residuals at the fixation area in the projection of the shank, which potentially was used for connection of rotary instrument’s parts by pasting technique. Considering obtained results it may be resumed that SEM analysis may be successfully used for identification and approval of counterfeit origin of rotary instruments, if such by the any signs of visual inspection, packaging or labeling features or macroscopic analysis demonstrate nonconformities, doubtful signs or suspicion of being counterfeit, but for effective realization of such approach SEM reference data of original items should be available.