Putting science in contextdistinguishing facts from speculation, significance from hype, importance from fashionis never easy.
The path from laboratory breakthrough to chairside therapy is long and tortuous. What captures the breathless attention of the media today may not have practical consequences for years, if ever; and not infrequently, the initial story turns out to be downright wrong. Putting science in contextdistinguishing facts from speculation, significance from hype, importance from fashionis never easy, even (or especially) for those closest to the subject.
This month, I am pleased to be able to offer you a new feature, called "Practical Science," which we at JADA hope will be of particular value to clinicians. From this time forth, these regular articles will be prepared in cooperation with the ADA Council on Scientific Affairs and the ADA Division of Science, drawing on the expertise of their members and that of outside contributors. The articles will generally contain neither previously unpublished data nor exhaustive reviews of the literature. Rather, they will present information selected to be of interest to clinicians. The goal is to present the information in the context of patient care, providing the scientific framework on which you can base your selection of the products and techniques best suited to your patients needs.
Our inaugural article in the Practical Science series addresses a topic of indisputable interest to every dentist and every patient: analgesics for pain control during and after dental procedures. In it, Dr. Arthur H. Jeske discusses some noteworthy current trends in this area. This information should help us decide which of the many options available provides the best pain management for a particular patient and procedure.
Rather than attempt a systematic review of all analgesic agents, the author has selected a few drugs (including the cyclo-oxygenase, or COX-2 inhibitor rofecoxib) for in-depth treatment. Why this particular selection? First, these are drugs that are approved for treatment of dental pain by the U.S. Food and Drug Administration, or FDA. Second, the COX-2 inhibitors are relatively new. And third, they act by mechanisms that are significantly different from those of our familiar, traditional dental analgesics.
In the United States, dentists generally have the same right to prescribe as physicians, and the same responsibility to exercise care and judgment in doing so. The FDA does much to help, by maintaining high standards for drug approval and information dissemination. We, however, bear the ultimate responsibility for our prescribing decisions.
What exactly is meant by "FDA approval"? For a drug to be FDA approved, it must undergo at least two double-blind, controlled clinical trials. If an analgesic is claimed to have a "dental indication," then those trials must have been performed in patients who actually needed relief from dental pain. We all know that pain originating in the mouth often is qualitatively different from, say, migraine headache. This is one reason why some otherwise effective analgesics do not have a dental indication: they simply may not work well for dental pain. For example, modern drugs for migraine headache target mechanisms specific to the condition, so there is no reason to believe they would be effective against routine oral pain.
On the other hand, a manufacturer may simply elect not to perform the (expensive) clinical trials required to obtain a dental indication. In these cases, its up to you to decideon the basis of the published evidence, plus your clinical experiencewhether and where to use the drug. Such "off-label" prescribing is both common and acceptable (though this may depend on state licensing laws). In fact, some of our most commonly used medicines are routinely prescribed in this way. Before using any unaccustomed pharmaceutical, regardless of approved indications, be sure to familiarize yourself with its mechanism, interactions and side effects. The Physicians Desk Reference, which summarizes information from the all-important FDA package inserts, is an excellent place to start. As dentists, however, your primary source of information on drugs is the ADAs own Guide to Dental Therapeutics.
I hope you find "Practical Science" both interesting and useful. In future issues, we are planning to address such subjects as environmental impacts and regulations, and the influence of new diagnostic techniques on patient care. I want to thank the Council on Scientific Affairs for taking on this important project. Im sure they will welcome your suggestions, both for what topics should be covered, and for how best to convey the information.