Conditions: Anesthesia
Keywords: operative dental procedure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 26
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.

A total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.

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: