Mechanical characteristics of counterfeit Reciproc instruments: a call for attention

Abstract

Aim: To report the main differences seen by direct visual inspection between original and counterfeit Reciproc instruments, together with an evaluation of instrument bending resistance, cyclic fatigue, surface finish, Vickers microhardness and chemical composition.

Methodology: The visual aspects of original Reciproc R25 (VDW, Munich, Germany) and counterfeit Reciproc R25 instruments (claimed to be original, supposedly with dimensions similar to those of Reciproc R25 files, bought at www.mercadolivre.com.br) were evaluated under direct observation, stereomicroscopy and scanning electron microscope. The flexibility of original and counterfeit Reciproc R25 was determined via 45° bending tests according to the ISO 3630-1 specification. Instruments were also subjected to cyclic fatigue resistance, measuring the time to fracture in an artificial stainless steel canal with a 60° angle and 5-mm radius of curvature. The fracture surfaces of all fragments were examined under a scanning electron microscope. Roughness of the instruments was quantified using a profilometer, and the microhardness test was carried out using a Vickers hardness tester. Energy-dispersive X-ray microanalysis (EDX) was also carried out. Results were analysed statistically using the Student's t-test at a significance level of P < 0.05.

Results: Although the packaging of the original and counterfeit instruments was similar, a number of differences were observed such as ISO colour coding, measurement marks, stopper and morphologic characteristics. Original Reciproc instruments had significantly longer cyclic fatigue life and significantly lower bending resistance than counterfeit Reciproc instruments (P < 0.05), as well as significantly lower microhardness and roughness (P < 0.05). EDX results revealed differences in the chemical composition of the instruments (P < 0.05), indicating that the instruments were manufactured with different raw material.

Conclusion: Original Reciproc files outperformed counterfeit instruments in all tests. It is thus important that identification strategies for these counterfeit instruments be developed, thereby preventing their inadvertent use.

Keywords: Reciproc; counterfeit endodontic files; endodontic; instruments; mechanical properties.