Microneedles enhance the efficacy of topical dental anesthesia in male subjects: a randomized controlled trial

This study aimed to determine whether microneedles (MN) can enhance the efficacy of a commercially available topical anesthetic (EMLA®) when applied to the palatal mucosa. In a randomized, double-blind, crossover trial, 30 male volunteers received bilateral applications of MN patches and flat patches (FL, without MN) on the palatal mucosa. EMLA® was subsequently applied for either 2 or 5 min in separate sessions. Immediately thereafter, infiltrative anesthesia was administered, and pain intensity associated with needle insertion and local anesthetic injection was measured using a 0-100 Visual Analogue Scale. No differences in pain intensity were observed during needle insertion or local anesthetic injection when MN and FL patches were compared, irrespective of the duration of EMLA® application. However, a significantly higher proportion of participants reported pain-free infiltrative anesthesia when EMLA® was applied for 2 min following MN pretreatment (40%) compared with FL pretreatment (10%) (p = 0.008). MN application was not associated with adverse effects. Pretreatment with MN enhances the clinical efficacy of intraoral topical anesthesia in males. These findings open new avenues for exploration of advanced transbuccal drug delivery technologies focused on fast-release systems that may improve clinical outcomes in topical dental anesthesia.