Receiving a report of “No cavities!” may be the best possible outcome of a visit to the dentist, but for those patients who need a filling, a newly approved anesthetic might make the procedure less painful.
Following a Phase 3 clinical trial led by Elliot Hersh, a professor in the Department of Oral and Maxillofacial Surgery/Pharmacology at Penn’s School of Dental Medicine, the U.S. Food and Drug Administration has approved a nasal spray anesthetic called Kovanaze for use before restorative procedures to the upper bicuspid, canine, or incisor teeth. The Penn study, which was published in the Journal of the American Dental Association, found that the spray was safe and similarly effective to commonly used injectable numbing agents.
The drug, developed by St. Renatus, is currently only approved for patients weighing 88 pounds or more, but Hersh is hopeful that further testing will allow it to be used on younger children as well.
“It would certainly make for a more stress-free dental office visit for children as well as adults if we could replace some of these anesthetic injections with a simple spray,” Hersh says.
To evaluate the safety and effectiveness of Kovanaze, Hersh and colleagues conducted a double-blind, randomized trial, recruiting 150 adult patients who passed a health screening and needed a single dental filling in an upper bicuspid, canine, or incisor.
Before their procedures, patients received either Kovanaze or a placebo, waited four minutes, then received a second spray. After another 10-minute wait, a test drilling was performed. If the patients experienced pain, they received a third spray. Patients who still experienced pain at that point received a rescue injection of local anesthetic to complete the procedure.
Hersh and colleagues found that Kovanaze prevented pain during the restorative procedure in 88 percent of patients, a rate of effectiveness similar to injectable anesthetics. Just 28 percent of patients who received the placebo were able to undergo the procedure without a rescue injection. The most common side effects of Kovanaze were runny nose and nasal congestion; no serious side effects were reported.
Future studies of Kovanaze may investigate whether it can provide sufficient numbing to perform more extensive dental work, such as root canals or oral tissue biopsies. Hersh is hopeful that this needle-free option will encourage more patients to address dental issues promptly, before minor problems turn into something worse.