Migraine
NO DRUGS, NO SURGERY
NEW DENTAL
DEVICE
PREVENTS MIGRAINE PAIN
AND MIGRAINE
ASSOCIATED TENSION-TYPE HEADACHE PAIN
The FDA has 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 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 migraine sufferers awake each morning with
varying degrees of migraine pain and have come to accept it as
normal.
Patients who experience such migraine 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
migraine 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 severe 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 migraine 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 migraine 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.
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