June 2, 2007
Millions of children, adolescents, and adults experience severe tooth pain each day due to broken teeth and cavities. There are many topical treatments for the relief of dental (tooth) pain, but none have been approved by the Food and Drug Administration (FDA) to establish their effectiveness.
If a patient cannot see a dental practitioner soon to receive the necessary treatments (removal of cavities, repair of fractured teeth), topical analgesics (pain relievers) can provide some temporary pain relief. Several topical gels currently available to consumers without a prescription contain the active ingredient benzocaine, which is helpful for providing temporary tooth pain.
The NYU’s Bluestone Center for Clinical Research is collaborating with several companies and research centers in an important study to determine how effective several different formulations of a topical benzocaine analgesic (pain-relieving) gel is for patients with acute tooth-ache pain. The purpose of the study will be to evaluate the efficacy and safety of two different concentrations of benzocaine gels compared to each other and placebo.
A second purpose of the study will be to assess the subject’s compliance with the dosing directions on the proposed label of the gel. The study will be double-blind, randomized (stratified by baseline pain: moderate dental pain versus severe dental pain), single-dose, placebo-controlled, parallel, multi-center.