A Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Placebo for Anesthetizing Maxillary Teeth in Adults

Abstract

Problem: Fear of a painful dental injection and subsequent avoidance behavior are significant barriers to regular visits to the dentist. An anesthetic procedure that would avoid the discomfort of a local anesthetic injection thus obviating fear and anxiety about receiving a "shot," would greatly benefit dental patients. Methods: The study employed a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth sufficient to allow completion of the Study Dental Procedure. A total of 36 subjects, randomized 2:1 (Kovacaine Mist: Placebo) were enrolled. Results: Kovacaine Mist was significantly superior to placebo (p<0.0001) with respect to the proportion of subjects who did not require rescue by injection of local anesthetic to complete the Study Dental Procedure. Conclusions: Based of the results of this clinical trial, a nasal anesthetic, such as kovacaine mist, could potentially be used as a safe and effective alternative to maxillary infiltration for anesthetizing maxillary premolars and anteriors to achieve pulpal anesthesia.