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A Phase II, Single-Center, Randomized, Double-Blind, Active-Treatment-Controlled, Parallel-Group Study of the Efficacy of Kovacaine Nasal Spray for Anesthetizing Maxillary Teeth in Healthy Dental Patients
The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures.
Details
| Lead sponsor | St. Renatus, LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 45 |
| Start date | 2008-12 |
| Completion | 2009-01 |
Conditions
- Dental Anesthesia Efficacy
Interventions
- 3% tetracaine HCL with 0.05% oxymetazoline HCL
- Lidocaine Injection
Primary outcomes
- Pulpal Anesthesia — Continuous throughout dental treatment period (up to 60 minutes)
Number of participants who did not need rescue anesthesia to complete the study dental procedure, i.e. Kovacaine provided enough pulpal anesthesia to complete a dental procedure.
Countries
United States