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

A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults

The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.

A total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.

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