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Migraine ?
NO DRUGS, NO SURGERY
NEW DENTAL DEVICE
PREVENTS MIGRAINE PAIN
AND MIGRAINE ASSOCIATED TENSION-TYPE HEADACHE PAIN
The FDA has recently granted marketing allowance for the NTI Tension Suppression System
(NTI-tss) indicated for the prevention and treatment of medically diagnosed migraine and
migraine-associated tension-type headache pain.
In a multi-center clinical trial, the new NTI-tss device was shown to significantly reduce or
eliminate migraine and migraine-associated pain. It is considered breakthrough technology in that
there is, when used as directed, no risk of side effects associated with it compared to many current
pharmaceutical migraine therapies.
Typical sufferers awake each morning with varying degrees of headache pain and have come to
accept it as normal.
Patients who experience such headaches contract their temporal muscles during sleep on average
14 times more intensely than patients who do not experience them, and have been found to exhibit
pericranial tenderness (muscle tenderness of the scalp). The NTI-tss device is a small, removable,
prefabricated, clear resin matrix oral insert that a dentist fits to the patient’s front teeth to be worn
while sleeping. With the NTI-tss device in place, the intense activity of the temporal muscle (which
closes and clenches the jaw) is suppressed to less than 1/3 of maximum by preventing any
contacting of the back molar teeth. By reducing this neuromuscular activity, migraine headache
pain is reduced or prevented all together, as well as the associated tension-type headaches.
In the United States, according to the results of the 1992 American Migraine Study that appeared
in The Journal of the American Medical Association, it is estimated that 23 million persons older
than 12 years of age suffer sever migraine headaches. The social and economic impact of migraine
is staggering, with estimates approaching $17.2 billion per year in lost productivity.
There is no known cause of or cure for chronic migraine. Commonly prescribed drugs have not
been shown to prevent or stop every incident of migraine, and their benefit does not exceed 50%
greater than treatment with placebo.
The pivotal NTI-tss clinical trial involved 94 patients. Each patient was diagnosed by a physician
as having at least two migraine episodes per month. Each patient was prescribed Imitrex®
(sumatriptan, GlaxoSmithKline) by a physician for use as a rescue medication. The patients were
divided into two groups. Fifty-one (51) patients were fitted with the control device, and 43
patients were fitted with the NTI-tss device.
After eight weeks of NTI-tss use, patients in the NTI-tss group did not experience any measurable
evidence of new pain or discomfort as a result of using the NTI-tss. The device did not cause pain
in use.
Clinical performance data showed a decrease of migraine episodes of 61.9% with the NTI-tss
device compared to 38.1% with the control. (82% of the NTI-tss users had a 77% average
reduction of migraine events.)
The need for Imitrex® rescue for the NTI-tss group was reduced by 46.8% compared to 17.6%
for the control group.
The NTI-tss group showed a 78% reduction in nausea compared to a 40.4% reduction in the
control group.
NTI-tss reduced all head pain episodes by 46.9% compared to a 25.1% reduction by the control
and a 36.9% reduction in the intensity of head pain versus a 23.7% reduction by the control.
In our office, we can fabricate the removable NTI-tss device in one visit. The device is worn
primarily while asleep. Many dentists across the country are already highly experienced in its use
after years of providing the NTI-tss for its earlier indications for the prevention of TMJ syndrome,
grinding, clenching, and bruxism. Approximately 200,000 patients have been treated to date for
these indications.
TMJ pages on our site: Click Here
Those seeking more information about the NTI-tss and its use in preventing migraine pain should
call our office at: 770-614-7300.
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