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Kovacaine Nasal Spray for Anesthetizing Maxillary Teeth
NCT01302483Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2008
- Primary completion
- Jan 2009
- Countries
- 1
- Sponsor
- St. Renatus, LLC
- Modality
- Implantable Devices, Transdermal Patches, Inhalation Devices
- Conditions
- dental anesthesia
01
Overview
Phase 2, randomised, double-blind trial of tetracaine HCl + oxymetazoline HCl in dental anesthesia (2 arms), sponsored by St. Renatus, LLC. Primary endpoint: Pulpal Anesthesia Success at 60 minutes. Started Dec 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Kovacaine Nasal Spray
3 sprays (100 uL) in each nostril + sham injection
Lidocaine Injection
Lidocaine injection + sham nasal spray
03
Who it enrols
Healthy adults requiring a restorative procedure on a single maxillary tooth (excluding 2nd/3rd molars).
04
Endpoints
Primary
Pulpal Anesthesia Success
Secondary
Soft Tissue Anesthesia Duration
Maximum Change in Pulse From Baseline
Maximum Change in Blood Pressure From Baseline
Maximum Change in Pulse Oximetry From Baseline
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