Diane Sawyer: 23 million Americans suffer from severe migraine headaches.  That was a figure that really stunned me, and who of us hasn't had a tension-headache or sinus headache?  This morning we're going to show you how this tiny piece of plastic could be able to change all of that and really ease the pain.

Diane: Well, a simple device has just been approved by the FDA and it could be what the doctor ordered for 40 million Americans who suffer from migraines, tension headaches, all kinds of headaches.  It's called an NTI and you wear it over your two front teeth at night (believe it or not) and apparently it helps prevent migraines, tension headaches and reduce the intensity of jaw clenching during sleep and really reduce the intensity of the headaches as well.
Joining us is Dr. James Boyd, a dentist who invented the device, and Ivy Mansky who's seen migraines, she says, virtually disappear since she's started using it.  Welcome to you both.  Ivy, let me start with you, how severe were your headaches?

Ivy: They were severe.  I would get two to three migraines a month, and I would get a sharp pain, that would repeat in one area where ever it would be, and I would just have to close my world off until it ended.
Diane: You started using this, you stumbled on it how?
Ivy:  My husband is a dentist here in Manhattan and he had been working with Dr. Boyd and found the NTI night piece mouthguard.  It's a type of device that has reduced the intensity of the clenching people do and he suggested that I wear it.  He had experienced me having these migraines and he said, "Try this". 

Diane: All right, so your husband worked with Dr. Boyd, and Dr. Boyd, I can hear people sitting at home saying, "Wait a minute, here, wait a minute".  First of all, the critics of this have said it can not be this simple, it can not work this simply, that migraines are caused by a variety of things, and you can't tackle them with one little piece of plastic.
Dr. Boyd:  Right.  When you hear the term "jaw clenching", it's hard to make that association, that leap to migraine, and they're not the same thing, of course.  There really is a "neurologic storm" that happens during a migraine event and what we've been trying to do is reduce this "kindling" that precedes this storm.  By reducing the intensity of muscle contraction of the patient's scalp while they're asleep, you reduce the frequency of the migraine events. 

Diane:  So you think that migraines are exacerbated by what, by this clenching of the nerves all over the skull and that's what your attacking?
Dr. Boyd: Exacerbated might be a good term to use, in that this jaw muscle contraction, and when most people think jaw muscle contraction they think about this jaw muscle (gestures to the lower jaw), when in fact, the most intense muscles of clenching the jaw is up here on the temples.  They squeeze this way, you can feel them bulge in and out when you jaws together.  If that muscle is allowed to contract with high degrees of intensity, which by the way is what migraine patients do when they're asleep,  they frequency of migraines can be increased.

Diane:  What results are you saying that you've seen from this?
Dr. Boyd:  In our clinical trials, 82% of migraines patients had a 77% average reduction in their migraine frequency.
Diane: In frequency? 
Dr. Boyd: Right.
Diane:  77%.  That's big.  You said that you had migraines, too?
Dr. Boyd:  I had a headache everyday, all day long, for 12 years.  I woke up in the morning, took my 4 Excedrin to get out of bed, took about 12 all day long, just to deal with my chronic headache and frequent migraines.

Diane:  Well, the critics have also said, "Hey, this is going to cause some other kind of problem.  Maybe it'll take awhile, but if you sleep in something like this, you'll be 'dislodging' your jaw in some different way and it'll show up later".
Dr. Boyd:  I think it's sort of a knee-jerk reaction.  In dentistry, the concept is "make sure your teeth fit together perfectly".  You know how when you have a filling done,  they always want to check your teeth to see if they fit together just right?  The problem with this (clenching) condition is they put their jaw together and squeeze them, tightly.  Well all this device does is reduce the intensity of nighttime jaw clenching.  All humans clench their jaws at night, it's the intensity that drives the condition.

Diane:  Again, we said that the FDA just recently approved this.  So Ivy, what's it like to sleep with this?  Did it drive you crazy?
Ivy:  Well, the first night it drove me crazy.  It disrupted my sleep, I kept waking up and taking out.  Then I wore it in an afternoon and I thought let me conscientiously cooperate with this and it took me three nights to get used to it.  In the six months that I've been wearing it, I've went from 2 to 3 migraines a month to having just one migraine in the last six months, which has been incredible.

Diane:  And these are available generally?...
Dr. Boyd:  At the general dentist's office.

Diane:  At the general dentist's office.  All right, if you want more information on NTIs, you can always go to our website and we'll tell you more about it at abcNEWS.com as you well know.  We thank you both for coming here this morning.  I know people who have these headaches are desperate, desperate, for something that might help.