Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

Inclusion Criteria: * Male or female between 18 and 65 years of age * Sufficiently healthy as determined by the investigator to receive the test and control medications and undergo the scheduled dental procedure * Required an operative restorative procedure on a single maxillary tooth, other than a maxillary second or third molar, with treatment time not expected to exceed 60 minutes * Could breathe through both nostrils * Had normal lip, nose, eyelid, and cheek sensations * Could understand and sign the informed consent document * Could communicate with the investigator * Could understand and comply with the requirements of the protocol Exclusion Criteria: * Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, cardiovascular, psychiatric, musculoskeletal, neurologic, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease or disorder or a clinically relevant history or presence of angle-closure glaucoma * Clinically relevant sinus/nasal surgical history * Baseline Visual Analog Scale value of \> 36 (or greater than weak) at the treatment site * Had not had dental work requiring a local anesthetic within the last 24 hours or had taken pain medications within the last 48 hours * Required prophylactic antibiotics for subacute bacterial endocarditis (infectious endocarditis) * Allergic to or intolerant of tetracaine, benzocaine, other ester local anesthetics, or p-aminobenzoic acid (PABA), as found in PABA-containing sunscreens * Allergic to or intolerant of oxymetazoline, epinephrine, or preservatives in their solutions * Had a current condition, such as nasal congestion or sinus infection, that may have influenced responses to study medications * History of alcoholism and/or drug abuse * Had taken a monamine oxidase inhibitor within the past 3 weeks * Were nursing, pregnant, suspected of being pregnant, or trying to become pregnant (females were required to take a urine pregnancy test to rule out pregnancy) * Had used any investigational drug and/or participated in any clinical trial within 30 days of baseline