INTRODUCTION: Despite metallurgical advancements in the nickel-titanium file manufacturing process, file separation remains a concern. The purpose of this prospective clinical study was to assess the separation incidence of the reciprocating WaveOne file (Dentsply Tulsa Dental Specialties, Tulsa, OK) when used to prepare root canals of posterior teeth. METHODS: File separation incidence was assessed over an 18-month period in which 4 experienced and calibrated endodontists performed conventional endodontic treatment on posterior teeth using the WaveOne file system. The separation incidence was determined based on both the number of teeth and the number of canals instrumented during this time period. RESULTS: A total of 2,215 canals (711 teeth) were treated. Three instruments (two 21.06 and one 25.08) separated during use and were deemed to be irretrievable. The overall instrument separation incidence in relation to the number of canals shaped was found to be 0.13% (0.42% teeth). CONCLUSIONS: Based on the results of this study, the incidence of endodontic instrument separation when using the WaveOne reciprocating file was considerably low.
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