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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kovacaine Mist | Experimental | 3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in each nostril (bilateral dosing) administered 4 minutes apart |
|
| Kovacaine Mist and Placebo | Active Comparator | 3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in the right nostril and three sprays of placebo in the left nostril (right-sided unilateral dosing) administered 4 minutes apart |
|
| Placebo and Kovacaine Mist | Active Comparator | 3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in the left nostril and 3 sprays of placebo in the right nostril (left-sided dosing) administered 4 minutes apart |
|
| Placebo spray | Placebo Comparator | 3 sprays of placebo in each nostril administered 4 minutes apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetracaine HCl 3% and Oxymetazoline HCl 0.05% | Drug | Active Spray with deliverable volume of 0.1 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 20 minutes of final spray |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of GPPA for bilateral versus placebo administration | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick R Brain, DDS | Jean Brown Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
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| ID | Term |
|---|---|
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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|
| Placebo spray | Drug | Aqueous solution to deliver 0.1 mL per unit |
|
|
| 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 | 181 minutes |
| Mean highest EPT value reached for first molars (#3 and 14) | 181 minutes |
| Incidence of induction of PPA following the first, second and third doses of active drug administered unilaterally and bilaterally | 181 minutes |
| Correlation between positive responses on Subjective Numbness Assessment (DNA) and incidence of global EPT scores of 80 | 181 minutes |
| Systolic Blood Pressure | 181 minutes |
| Diastolic Blood Pressure | 181 minutes |
| Heart Rate | 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 | 24 hours |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |