New Dental Device Significantly Reduces Tension-Type Headaches.

CHICAGO--(BW HealthWire)--July 30, 1998--

-- FDA Marketing Allowance Granted for NTI System That Suppresses Clenching and Grinding --

-- Data Presented at Medical Conference Suggest Potentially Broader Application --

A new dental device that minimizes the pain and discomfort of headaches associated with chronic clenching and grinding of the teeth may have usefulness in treating other types of head pain, according to research results presented today at the 14th Annual International Symposium of the American Academy of Head, Neck and Facial Pain (AAHNFP).

James P. Boyd, D.D.S., director of the Headache Prevention Institute, based in Bloomfield Hills, Mich., who invented the Nociceptive Trigeminal Inhibition (NTI) Clenching Suppression System, presented results from clinical trials testing the device in people who experience chronic headaches. The device recently received marketing allowance from the U.S. Food and Drug Administration, and has been patentedin the United States and internationally. It is manufactured and marketed by Heraeus Kulzer, Inc., South Bend, Ind.

For much of his adult life, Boyd suffered from daily morning headaches and occasional migraine pain. After many years of intense research, he identified chronic clenching and grinding of the teeth, also known as bruxism, as one of the primary causes of tension-type headaches (defined as an ache in the area where the muscles of the head and neck meet). Rather than treating headache symptoms (pain and discomfort) with analgesics or muscle relaxants, common approaches to headache therapy, Boyd set out to reduce the discomfort created by this little known cause of headache pain.

"I had a debilitating headache all day, every day for 12 years straight," said Boyd. "And I knew there were millions of people out there experiencing the same excruciating pain. Taking aspirin 12 times a day wouldn't make it go away, so I knew it was time to go directly to the source of the pain. This device is the answer."

The small, semi-custom NTI appliance, which must be fitted by a trained dentist, covers the inside and outside of the two front, upper teeth in the mouth (teeth eight and nine). Once in place in a patient's mouth, a dome will come in contact with the lower incisors, preventing the upper and lower sets of teeth from touching one another. This renders the temporalis muscle incapable of contracting to its full potential, thus eliminating bruxing and the resulting headache pain.

The non-drug device does not introduce any chemicals or substances into the patient's system, and therefore poses no threat to the patient's health. The device can be worn at night and during stressful times.

Clenching and grinding, both types of temporo-mandibular disorder (TMD), have recently become more widely recognized as underlying causes of tension-type headaches, and possibly of migraine pain. During clenching and grinding, the temporalis muscle, the primary function of which is to control movement of the jawbone, becomes hyperactive.

"Clenchers" and "grinders" are often unaware of their condition, as the harmful action takes place during sleep, deep concentration, or stressful episodes. Upon waking in the morning or after mentally taxing periods, bruxism patients frequently experience moderate to severe headache pain as a result of the clenching or grinding.

According to the National Headache Foundation, more than 45 million Americans suffer from chronic, recurring headaches; Americans spend more than $4 billion on over-the-counter headache medications; and employers lose $50 billion because of headache-related absenteeism and medical expenses.

"About 70 percent of people who experience headaches have some improvement, if not complete elimination of their pain when they use this device," said Boyd. "People are very surprised when they find out that a small, comfortable device in their mouth when they sleep can relieve the pain they've been living with for years."

In his AAHNFP presentation, titled, "Identifying Medically Diagnosed Tension-Type Headache and Common Migraine as a Temporalis Disorder: New Concepts in Etiology and Treatment," Dr. Boyd discusses the advantages of the NTI device over currently used splints and other treatments.

The AAHNFP was founded in 1985, to fill a need for more widespread knowledge of the diagnosis and treatment of head, neck, and face pain, and temporo-mandibular disorders. A second objective of the academy is to seek specialty status for those whose main professional interest is in the clinical treatment of head, neck, and face pain patients. The academy's headquarters is located in Hurst, Texas, and its membership comprises more than 500 medical and dental professionals.

Headquartered in Hanau, Germany, Heraeus Kulzer, Inc. is the dental business unit of Heraeus, Inc., a privately held, technology-based corporation with interests in the medical, aerospace, jewelry, and electrical markets, employing over 10,000 people worldwide. As the third largest dental manufacturer in the world, Heraeus Kulzer, Inc. offers one of dentistry's widest selections of high quality laboratory and operatory products, ranging from precious metals to tooth-colored restorative materials. Heraeus Kulzer's U.S. operation is located in South Bend, Ind., and has a continuous

history of active participation and leadership in the dental industry, dating back to 1887.

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