Dental pain relief without drugs? The FDA says yes, recently certifying the first cryoanesthetic dental mouthpiece for the U.S. over-the-counter market. Used as an anesthetic device, gumEase® provides pain relief without the side effects or complications of drugs. It's a tempting solution for clinicians plagued with patient needle phobia, sharps and the complex issues of hypodermic delivery.

The easy-to-use, latex-free, disposable device is inserted onto the upper and lower sulci.  gumEase® delivers a soothing, cool temperature to the maxillofacial nerves and works simultaneously on all four quadrants of the mouth.  The impact of cooling the nerve fibers results in the denial of pain being transmitted to the brain during the procedure.  Consequently, the patient feels no discomfort during the procedure.  The gumEase® device is well above and below the teeth and gum line, so sensitivity to cold is not an issue.  gumEase® can also be used by patients post-operatively and reused without side effects by storing them in a household freezer.

"It gives dentists an option they didn't have before," says Tay McClellan, BioMeDevice CTO. "They can manage patient pain easily in a wider range of situations. Now it's not a problem to have a patient who can't use drug-based anesthesia."  The device also ends the necessity of needle disposal.

The gumEase® G100 is prepared by storing in a conventional freezer to 20 degrees F or -7 degrees C.  Proprietary solutions inside the mouthpiece prevent it from freezing, allowing it to form comfortably within the patient's mouth for several minutes.  It is recommended that two gumEase® be used depending on the procedure involved and the sensitivity of the individual patient.  The effect lasts for up to twenty minutes and another gumEase® can be applied if the procedure requires more time. A new, single unit gumEase® product will be available in 2009 that lasts for up to two hours and is specifically designed for lengthy surgical procedures.

gumEase® is effective for fillings, extractions, crowns, root canals, cleaning, braces adjustment and other procedures. 

Clinical Procedure Videos
Click here to watch videos of clinical procedures using gumEase®.  More...

Developed in Laguna Hills, California, by BioMeDevice, gumEase® component parts are manufactured by four American companies and assembled in Ireland.