June 27, 2013
Bluestone’s ability to quickly recruit the qualified patient population was integral to the success of the study.
As part of a multicenter study sponsored by Pfizer Consumer Healthcare and Church & Dwight, New York University College of Dentistry’s (NYUCD) Bluestone Center for Clinical Research (BCCR) recently participated in a nation-wide clinical trial assessing the safety and efficacy of 10 and 20 percent benzocaine gels for the temporary relief of toothache pain. Benzocaine is recognized as safe for the temporary relief of mouth pain due to minor irritation or injury from dental procedures, dentures, canker sores, teething, orthodontic appliances, or a sore throat.
The BCCR team was responsible for recruiting a substantial number of patients for the trial. The results of the study, “An evaluation of 10 percent and 20 percent benzocaine gels in patients with acute toothaches: Efficacy, tolerability and compliance with label dose administration directions” were published in the Journal of the American Dental AssociationMay 1, 2013; 144, 517-526
“Since the early 20th century, benzocaine has been used as a local anesthetic, applied directly to the painful areas of the mouth,” said Patricia Corby, DDS, MS, associate director of the BCCR. “Despite this long-term use, there was limited information available to demonstrate the effectiveness of benzocaine for the treatment of a toothache. “
The clinical trial, performed in collaboration with the Food and Drug Administration (FDA), evaluated the efficacy, tolerability, and patient compliance in administering the proper dose of 10 and 20 percent benzocaine gels. 576 participants reported toothache pain of at least moderate intensity in one permanent tooth with an open tooth cavity. These participants were randomly assigned to self-apply either placebo, 10, or 20 percent benzocaine gel according to their baseline pain levels.
To assess compliance with dose administration, participants were given a product label with directions on how much gel to apply to their painful tooth and surrounding area. Participants rated their pain according to the dental pain relief scale every five minutes during the first 30 minutes following gel application and then again at 10 minute intervals from 30 to 120 minutes following gel application.
The results showed that all gels were well tolerated and the majority of participants were able to correctly apply both the 10 and 20 percent benzocaine gel. Both the 10 and 20 percent benzocaine gels were more effective in relieving toothache pain than the placebo gel, with the 20 percent gel providing the most pain relief. These results indicate patients can safely self-administer 10 percent and 20 percent benzocaine gels to temporarily relieve toothache pain.
About the Bluestone Center for Clinical Research: The Bluestone Center for Clinical Research, in conjunction with the NYU Oral Cancer Center, is an academic research organization located at the NYU College of Dentistry. Bluestone’s mission is to take a creative scientific approach to transform world health. Bluestone is dedicated to conducting research in oral cancer, cancer symptomology, pharmaceuticals, medical devices, emerging biotechnology, periodontics, implants, and oral health products. Press contact: Andrea Flynn, AndreaN.Flynn@nyu.edu, 212-998-9892.