At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Kovacaine Mist 0.1 mL x 4 sprays +2 moredrug
Likely dose
Kovacaine Mist 0.1 mL x 4 spraysfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Single-Site, Open-Label Clinical Trial To Evaluate The Efficacy And Recommended Dosing Regimen Of Kovacaine Mist Administered Unilaterally For Anesthetizing Maxillary Teeth In Healthy Dental Patients
In Brief
A Phase 2 clinical trial evaluating Kovacaine Mist 0.1 mL x 4 sprays, Kovacaine Mist 0.2 mL x 2 sprays, and 1 other intervention for Anesthesia. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary teeth for dental procedures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesUnited States
CollaboratorsRho, Inc., Triligent International
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartJan 2012
Primary CompletionApr 2012
TodayJul 2026
First PostedNov 24, 2011
Enrollment StartJan 1, 2012
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.6 years ago
Interventions
Kovacaine Mist 0.1 mL x 4 spraysdrug
Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.
Kovacaine Mist 0.2 mL x 2 spraysdrug
Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.
Kovacaine Mist 0.2 mL x 1 spraydrug
Dose = 1 intranasal spray of study drug