NCT02457806

Comparison of Anesthetic Efficacy of Bilateral and Unillateral Application of Kovacaine Mist in Healthy Volunteers

Phase 1, Randomized, Double-Blind, Placebo-Controlled, 4-Period, Complete Cross-Over Comparison of the Anesthetic Efficacy of Bilateral and Unilateral Application of Kovacaine Mist in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: St. Renatus, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To compare the efficacy of Kovacaine Mist administered bilaterally to that of Kovacaine Mist administered unilaterally with respect to global profound pulpal anesthesia in target teeth numbers 4-13.

Detailed description

Qualified and consenting healthy subjects will be randomly assigned in a double-blind manner to sequences of four randomly ordered study periods with inter-treatment "washout" periods of 3 to 14 days. The four study regimens, which will be applied in random order will be: * Regimen1. Three sprays of Kovacaine Mist in each nostril (bilateral dosing); * Regimen 2. Three sprays of Kovacaine Mist in the right nostril and three sprays of placebo in the left nostril (right-sided unilateral dosing); * Regimen 3. Three sprays of Kovacaine Mist in the left nostril and three sprays of placebo in the right nostril (left-sided unilateral dosing); * Regimen 4. Three sprays of placebo in each nostril (placebo dosing). During each testing period, eight representative maxillary teeth (#s 3, 4, 6, 8, 9, 11, 13 and 14) will be assessed for anesthesia using standard EPT testing. EPT testing will be conducted on the eight representative teeth at the following time points (minutes relative to the first spray of study drug): T-5, T3, T7, T11, T16, T21, T26T31, T41, T51, T61, T76, T91, T121, T151, and T181. If EPT testing of a target tooth is not possible (e.g., missing or does not meet inclusion criterion #2) tooth substitution is permissible. For molar teeth, #2 may replace #3 and #15 may replace #14. For premolar teeth, #5 may replace #4 and #12 may replace #13. The same replacements will be made for all testing sessions, and the actual teeth tested will be documented in the CRF.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Active Spray with deliverable volume of 0.1 mL
DRUG	Placebo spray	Aqueous solution to deliver 0.1 mL per unit

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2015-05-29
• Last updated: 2016-11-10

Locations

1 site across 1 country: United States