Anesthesia Clinical Trial
Official title:
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
The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.
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 maxillary teeth will be categorized in two subsets,
anteriors (teeth numbers 6 to 11) and premolars (teeth numbers 4, 5, 12 and 13).
The intent is to treat 150 subjects at 3 study sites, 2:1 randomization within each study
site, and an overall goal of 100 subjects treated with Kovacaine Mist and 50 treated with
placebo. Recruitment will be from diverse dental patient populations with at least 25% of
subjects over 50 years of age. Randomization will be within strata defined by age (≤50 and
>50 years).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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