Conditions: Anesthesia
Keywords: operative dental procedure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.

Detailed description:
This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.

The study will employ an open-label design to determine the lowest effective doses (LEDs), and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure, and will be carried out in healthy children of either sex between the ages of 3 and 17 years, inclusive.

Arms:
arm 1: 400uL of Kovacaine Mist, as 2 sprays of 200uL. arm 2: 200uL of Kovacaine Mist, as 2 sprays of 100uL. arm 3: 120uL of Kovacaine Mist, as 2 sprays of 60uL.

Interventions: intervention 1: 400uL of Kovacaine Mist intervention 2: 200uL of Kovacaine Mist intervention 3: 120uL of Kovacaine Mist
Intervention descriptions: intervention 1: 2 unilateral intranasal sprays of 200uL each. intervention 2: 2 unilateral intranasal sprays of 100uL each. intervention 3: 2 unilateral intranasal sprays of 60uL each.

Protocol document: