Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth

Inclusion Criteria: * Male or female 18 years of age or older. * Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology. * Normal lip, nose, eyelid, and cheek sensation. * Able to understand and sign the study informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol. * Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure. * Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive. * Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive. Exclusion Criteria: * Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg). * Inadequately controlled active thyroid disease of any type. * Frequent nose bleeds (≥ 5 per month). * Having received dental care requiring a local anesthetic within the last 24 hours. * History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen). * History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives. * Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry. * Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.) * Having received any investigational drug and/or participation in any clinical trial within 30 days prior to study participation. * Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure. * History of congenital or idiopathic methemoglobinemia