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Professional News Articles : : ON PRACTICE MANAGEMENT by Janyce Hamilton : FDA approves use of NTI NightGuard to help prevent migraines

FDA approves use of NTI NightGuard to help prevent migraines

August 07, 2006

What's new in dentist-dispensed products and services that cure non-dental conditions? The “NTI” – a dental device approved specifically to prevent migraine headaches. In the seemingly growing array of medical add-ons available at dental practices, this one's FDA nod enhances credibility nicely.

Below, the NTI's inventor, James P. Boyd, DDS, Practicing Clinical Consultant, The Headache and Neurology Center of Southern California, and the President and CEO of NTI-TSS, Inc., based in Mishawaka, IN, talks about the device.

The Interview

Janyce Hamilton (JH):  What does NTI stand for and how did you invent it?

James Boyd, DDS (JB): Nociceptive Trigeminal Inhibition. The invention was simply an improvement on the design of the traditional anterior deprogrammer. I had modified my own full coverage splint to reduce my clenching intensity by providing incisal contact only in centered clenching, but soon realized that my jaw had other ideas while I was sleeping, in that I began to experience symptoms that were new to me.  My clenching pattern seemed to adapt in its effort to find a platform to clench against.  I had begun protruding to clench, and then moving excursively to clench.

Eventually, the design became an enhanced deprogrammer, whose design was intended to not only prevent posterior contact, but canine contact as well, while minimizing condylar translation during parafunctional events.
What I had come up with was not a new concept to dentistry, that is, incisal guidance during parafunction. What I patented was the pre-fabrication of a device that could be customized by the provider per patient.

JH: Are you the owner or is it owned by NTI/TSS in Indiana?

JB: NTI-TSS, Inc. owns the patents, and I am the majority shareholder.

JH: So, has the NTI cured your migraines 100%?

JB: Well, for me, yes, in as much as my eyesight is also cured when I wear my glasses. Migraine is a disorder of the sensory portion of the trigeminal nerve, in that the trigeminal sensory nucleus responds to seemingly normal stimuli (a trigger) with an abnormal response (that ends up causing inflamed and swollen cranial arteries and sinuses). The majority of migraineurs also have a hyperactive trigeminal motor root, that is, they are nocturnal jaw-clenchers to some degree (usually it's quite intense).  The chronic clenching serves to bombard the sensory nucleus with noxious stimuli, thereby making their susceptibility to migraine triggering far greater. 

This has been where the big disconnect between dentistry and medicine has occurred. Dentistry restores the damage and treats the pain of this temporomandibular disorder, while medicine prescribes drugs to reduce the frequency of painful neurological disorders.  Both are treating the aftermath of a hyperactive/hypersensitive trigeminal nerve.

JH: How much does it cost the patient? The dentist?

JB: I think the average fee that the dentist charges in the range of $500.
The dentist can either buy a pre-fabricated NTI-tss device (that he then retrofits chairside) for $20, or he can send models to Keller Lab to have an NTI-plus made (their fee is ~$110) (Keller's NTI-plus ends up looking a lot nicer than the chairside fabricated device).

JH:  I am a “migraineur” three days a month, thus, the NTI appeals to me, if my etiology is clenching-related, rather than taking sumitriptan medication. How would I know?

JB: The triptans are blocking the neuropeptides that the trigeminal nerve decided to secrete around your cranial arteries (and then later into your sinuses), while the NTI reduces the noxious stimuli to the trigeminal nerve, thereby making it less likely to make such a decision.

You'd be an appropriate NTI candidate upon answering the following question:

On a scale of 0-10, with 10 being the worst discomfort imaginable above the shoulders, and a 0 is no discomfort or pain at all (that is, you feel fabulous), how many mornings per week do you wake with a ZERO, that is, you feel fabulous?

An NTI candidate might hesitate before answering, and then proceed to explain why they feel the way that they do upon waking. They usually have a justification for their discomfort/pain. Essentially, a nocturnal clencher thinks that feeling fabulous isn't normal. . . while a degree of usual-and-customary discomfort is.

JH: For those with anti-snoring mouthguards for getting better sleep, do they forego the anti-snoring benefits of their device and try an NTI and see if it also has anti-snoring properties, along with the anti-migraine properties (which I understand reduce migraine pain attacks by 77% in your study) or not?

JB: This is an area that healthcare providers would struggle with. Whereas apnea considerably compromises the patient's health, migraine pain considerably compromises the patient's quality of life (while not necessary threatening their health). 

Does the patient's anti-snoring mouthguard provide posterior contact? If so, then a TAP appliance (a snoring appliance that provides anterior midline contact only) or SnoreHook Discluder (an anti-clenching device that prevents the retrusion of the mandible) would be the appropriate combination device.

JH:  Tell me about NTI's successes.

JB: We are now (Andrew Blumenfeld, MD, and myself) finalizing a study of migraineurs who were treated with the NTI for publication. Twenty migraine sufferers, who were referred to our clinic from other MDs (The Headache Center of Southern California is considered a tertiary care facility, in that patients have already seen their primary care doctor, and then a specialist) were treated with an NTI for two months Each of the 20 completed a questionnaire, to determine the impact their headaches were having on their lives.

Each sufferer's score indicated that their pain was having a severe negative impact on their lives. The physicians in the group continue to be impressed that 70% of the refractory migraineurs they see continue to have such profound improvements in their lives.

Conclusion

Watch the dental literature for studies published on the NTI device, or contact the manufacturer for advance data. In the meantime, I might be trying it myself.

For more information, the website for dentists is:  http://www.nti-tss.com;  the website for patients is: http://www.headacheprevention.com.

Janyce Hamilton is a Chicagoland freelance dental writer and editor. Send suggestions for topics to be covered, or any comments on this column, to review@cds.org.

Copyright 2006, Chicago Dental Society