Study of the Efficacy and Safety of Local Dental Anesthetics : Articaine Hydrochloride and Hydrogen Tartrate Adrenaline Injections (OKAD01) versus Lidocaine Hydrochloride and Hydrogen Tartrate Adrenaline Injections (A Phase Ⅲ Study of Articaine Hydrochloride)

Abstract

  This was a domestic phase Ⅲ clinical trial to evaluate the efficacy and safety of a dental local anesthetic, articaine hydrochloride/hydrogen tartrate adrenaline injections (OKAD01 : articaine), and compare them with those of lidocaine hydrochloride and hydrogen adrenaline tartrate injections (lidocaine).

  Japanese adult patients who underwent the extraction of a mandibular semi-implanted wisdom tooth were included in this study. Two to 3 cartridges of articaine or lidocaine were administered in combination with an inferior alveolar nerve block and infiltration anesthesia or infiltration anesthesia alone, and the mandibular impacted wisdom tooth was extracted. The primary outcome was the patient’s pain during the dental procedure according to a visual analog scale (VAS) (0–10 cm).

  The mean (95％ confidence interval (CI) ) VAS score was 0.90 (0.32 to 1.48) for the articaine group (42 patients) and 1.37 (0.63 to 2.11) for the lidocaine group (44 patients). The mean difference in the VAS score (articaine group-lidocaine group) (95％ CI) was −0.46 (−1.39 to 0.47), and the upper confidence limit was lower than the equivalence limit of 1.0, confirming the non-inferiority of articaine compared with lidocaine (p＝0.0012). No adverse events related to the study drug were observed in either group.

  This study confirmed the non-inferiority of articaine compared with lidocaine in terms of efficacy, and the safety profile of articaine was comparable to that of lidocaine.