Conditions: Anesthesia
Keywords: operative dental procedure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 110
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

Detailed description:
The study will employ 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 numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.

The intent is to treat 110 subjects, with enrollment balanced evenly between the 2 study sites, 2:2:1 randomization within each study site and an overall goal of 44 subjects treated with Kovacaine Mist, 44 treated with Tetracaine alone, and 22 treated with Placebo. Recruitment will be from diverse dental patient populations.

Arms:
arm 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% arm 2: Tetracaine HCl 3% arm 3: Placebo

Interventions: intervention 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% intervention 2: Tetracaine HCl 3% intervention 3: Placebo
Intervention descriptions: intervention 1: 3 unilateral intranasal sprays per dose intervention 2: 3 unilateral intranasal sprays per dose intervention 3: 3 unilateral intranasal sprays per dose

Protocol document: