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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
48
Active Spray with deliverable volume of 0.1 mL
Aqueous solution to deliver 0.1 mL per unit
Jean Brown Research
Salt Lake City, Utah, United States
Achievement of GPPA by teeth reaching an EPT of 80
Achievement of Global Profound Pulpal Anesthesia (GPPA) as having all three target maxillary teeth \[nos. 4(or 5), 6, and 8 for the right side or nos. 9, 11, and 13 (or 12) for the left-side\] reach an EPT of 80 within 20 minutes of the final spray of study drug
Time frame: 20 minutes of final spray
Incidence of GPPA for bilateral versus placebo administration
Time frame: 20 minutes of final spray
Incidence of PPA for individual teeth
For all individually EPT-tested teeth the incidence of Profound Pulpal Anesthesia (PPA) defined as reaching an EPT of 80 within 20 minutes, with unilateral and bilateral drug administration
Time frame: 181 minutes
Time to onset and duration of PPA
For all individually EPT-tested teeth achieving PPA, time to onset and duration of PPA for unilateral and bilateral drug administration
Time frame: 181 minutes
Mean highest EPT value reached for first molars (#3 and 14)
Time frame: 181 minutes
Incidence of induction of PPA following the first, second and third doses of active drug administered unilaterally and bilaterally
Time frame: 181 minutes
Correlation between positive responses on Subjective Numbness Assessment (DNA) and incidence of global EPT scores of 80
Time frame: 181 minutes
Systolic Blood Pressure
Time frame: 181 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Diastolic Blood Pressure
Time frame: 181 minutes
Heart Rate
Time frame: 181 minutes
Adverse experiences spontaneously reported
Adverse experiences spontaneously reported by subjects, or observed by study personnel including those encountered on nasal and airway examination (NAE), incidence rates for systolic and diastolic blood pressure and heart rate exceeding +/- 25% of pre-study values
Time frame: 24 hours