The study purpose was to determine safety and efficacy of Tetracaine nasal spray for anesthesia of maxillary teeth for a dental procedure.
Methods:
This double-blind, randomized study was in healthy male and female subjects, age 18 to 65, needing a single restoration on a maxillary tooth, excluding second or third molars, with treatment time not expected to exceed 60 minutes; could breathe through both nostrils and had normal lip, nose, eyelid, and cheek sensations. 25 per protocol subjects received a Tetracaine nasal spray and 15 a Lidocaine injection. At baseline either an intraoral Lidocaine injection and a placebo nasal spray or a sham injection and Tetracaine nasal spray were administered. Additional doses of nasal spray were given at 4 and 8 minutes. A visual analog scale (VAS) for pain was administered 15 and 20 minutes after the first dose. Dental treatment was to begin immediately after the first post-dosing VAS. If the patient reported pain, dental treatment was not to begin until 20 minutes after dosing start. Assessment of soft tissue anesthesia was done prior to dosing, and at 20, 30, 40, 50, 60, 80, 100, and 120 minutes. Results:
Treatment success, defined as ability to accomplish the dental procedure without need for rescue medication, was achieved by 22 of 25 per protocol subjects (88%) in the Tetracaine nasal spray group and 14 of 15 subjects (93%) in the Lidocaine Injection group. The difference between groups was not statistically significant, p=1.0, using Fisher's Exact Test.
Conclusion:
Results showed that nasal Tetracaine was well tolerated and provided anesthesia of the maxillary teeth sufficient for the performance of operative dental procedures. These results support further clinical trials. Supported by a grant from St. Renatus, LLC.