No poke, no pain. FDA-approved mouthpiece takes needles away from dental visits

Dental pain relief without drugs? The FDA recently approved the first cryoanesthetic dental mouthpiece. The new gumEase® makes visits to the dentist a whole lot easier, eliminating the need for shots. It's big news for the millions who can't or don't wish to use conventional hypodermically-delivered anesthesia.

The easy-to-use, disposable device is a breakthrough in pain management. It's as effective as it is inexpensive. "A regional pain block is achieved by the local application of extreme cold via the gumEase® to the maxillofacial nerves. The nerve fibers are chilled/frozen and can no longer transmit pain impulses to the brain"-that's how the gumEase® works. Patients can apply them post-operatively as needed and reuse without side effects by storing in a household freezer in accordance with directions provided.

"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 holds promise for situations where needle use is limited; such as the developing world.

The gumEase® is stored in a temperature controlled freezer until freezing temperature is reached. The mouthpiece is made of a proprietary noDOP PVC biocompatible compound allowing it to form comfortably within the patient's mouth. Then over the next few minutes the maxillofacial nerves, the primary pain receptors in the mouth, are essentially "put to sleep" even after warming to body temperature.