Ten years ago the FDA (U.S. Food and Drug Administration)
approved the first non-pharmaceutical treatment for
migraine headaches, the NTI-tss. Since then, more than
20,000 dentists worldwide have prescribed more than one million
The developer of the NTI therapeutic protocol, James Boyd,
DDS, recognized that patients in his general practice who suffered
from frequent migraines had a common symptom –
morning headaches. "Even though these patients would report
of some days being relatively migraine-free, they reluctantly
admitted to waking with some degree of discomfort every
morning," says Boyd.
While some of Boyd's patients responded favorably to full
arch occlusal splint therapy, those who reported chronic morning
headaches seemed less predictable, with some even worsening
with these splints. After reviewing the occlusion on these
cases and looking for similarities, Boyd realized the occlusal
scheme wasn't predictive of who would or would not respond to
splint therapy. Instead of occlusion, Boyd postulated that
occluding was the problem. "As Henry Tanner used to say, 'it
isn't what you have, it's what you do with what you have that
causes and perpetuates the pain,'" says Boyd. He identified these
chronic headache patients in his practice as primary clenchers,
and his goal became finding a way to reduce and control the
intensity of that parafunctional activity.
His development of a parafunctional control protocol, using
an appliance design that was effective, durable, comfortable and
cost effective for both the dentist and the patient, took nearly a
decade, changing as Boyd's knowledge and insight of the medically
diagnosed migraineur evolved. Boyd's patents are based on
the provision of a prefabricated, enhanced discluding element,
which provides immediate and continuous incisal guidance in all mandibular movements by preventing posterior and canine
contact on both the device and the opposing dentition.
After years of teaching the NTI therapeutic protocol to dentists,
Boyd developed a new professional relationship that would
have even wider repercussions for NTI use and credibility.
Andrew Blumenfeld, MD, a neurologist and recognized
researcher in the field of headache and migraine, is director of
The Headache Center of Southern California. "The more we
discussed each other's field of expertise, the more we realized
that we were talking about nearly the same thing, that both
migraine and temporomandibular (TM) disorders were trigeminal
nerve disorders: TMD resulting from trigeminal motor
hyperactivity; and, migraines the result of trigeminal sensory
dysmodulation. What intrigued us was the probability that
either one may cause or influence the other."
Within the last three years Dr. Blumenfeld has presented
research highlighting the NTI's migraine prevention efficacy in
his practice at migraine research symposiums in Los Angeles,
London, Philadelphia and Nice. Starting this fall, The
Headache Center, in collaboration with Dr. Boyd, will initiate
its most significant NTI research to date.
"No one in the migraine field disagrees that sleep has a
considerable influence on headache frequency and intensity,"
says Blumenfeld. "What we don't fully understand is what
exactly it is about sleep that is so influential. We will be doing
a polysomnogram on 100 consecutive chronic migraineurs,
complete with EMG recordings of temporalis activity.
Following eight weeks of NTI use, we will repeat the sleep
study (while the subject uses their NTI). Our hypothesis is that
those who've reported the most relief will be those who've had
the most significant reduction in temporalis activity."
Although future research promises even more details on
how NTI achieves prophylactic and treatment success for
migraine pain, both Drs. Boyd and Blumenfeld remain dedicated
to combating current myths about NTI use.
Dentaltown Magazine had the opportunity to ask the doctors
a few questions about NTI treatment. Below they address
the benefits and concerns about the device to aid acceptance
within the dental community.
Some practitioners warn against "long-term" NTI
use, due to possible posterior supraeruption and
incisor intrusion. Are you concerned as well?
Boyd: I asked my local orthodontist a hypothetical question.
"If I needed you to extrude the most distal molar on one
of my patients, but you were restricted from attaching any
brackets to the molars, and could not use a removable device
that touched the molars, and there would be no means of treatment
throughout the day, could you do it?" The answer was no!
That is, however, exactly what some dentists claim an NTI can
do! As far as tooth movement in a general sense is concerned,
there just isn't the means to forcefully extrude or intrude any
teeth. However, that is not to say that the "one-in-1,000" case is
not out there. With more than one million NTI devices in use,
I have seen and heard of almost everything.
What about aspiration? It that a concern?
Boyd: I wonder how many acrylic temporary crowns are dislodged
and swallowed or aspirated every night. I can't count
how many times a patient has arrived for their permanent crown
delivery, only to find their temporary crown missing, with the
patient having no idea that it was gone. Proper NTI protocol
adapts the NTI device onto unprepared teeth. Of course there
is always a degree of risk inherent in all intraoral removable
devices, but of more than a million NTI devices delivered, no
more than three occurrences of aspiration have ever been
claimed, and none verified radiographically or otherwise.
There are reports of anterior open bites "caused"
by NTI use. Given the litigious nature of society,
should a dentist even bother providing an NTI?
Blumenfeld: In the medical field, and especially in
migraine prevention therapy, all of the medications we use
have side effects, and some of those are particularly undesirable.
With NTI therapy, we inform the patient that in a small
minority of cases, a degree of change in their bite might occur
and then a shared decision is made. In certain medical conditions
the NTI becomes a first line choice.
Boyd: When I examine a potential candidate for NTI therapy,
I note the degree of incisal overlap. If the overlap is minimal, or
edge-to-edge, I advise the patient that an NTI can reveal orthopedic
relationships that were previously not noticeable, meaning, the
way their lower jaw fits up against their upper jaw could change.
Are there circumstances when the NTI is contraindicated?
Blumenfeld: There are no medical contraindications. There
is no treatment that will help everyone. When it comes to
migraine prevention, we like to prescribe an NTI to rule out
nocturnal parafunction. Certainly not all migraines are affected by nocturnal parafunction like clenching intensity, but we find
ruling out, or identifying and controlling nocturnal parafunction
enhances our treatment efficacy.
Boyd: Because I see mostly refractory migraineurs now, a
strict adherence to protocol is essential. For those with a compromised
joint, the practitioner must confirm that the NTI does
not complicate their condition further. That is not to say that an
NTI is contraindicated for degenerative joint disease; in fact,
quite the contrary. In the presence of nocturnal parafunction,
the goal is to minimize muscle contraction intensity while minimizing
joint strain and load, which a properly provided NTI
allows for. However, simple oversights such as allowing for
excessive vertical dimension in extreme protrusive can further
complicate a patient's presentation. Just as a general practitioner
is licensed to perform complex oral surgery, it would be considered
"contraindicated" for the generalist to do so. The same
exists with NTI therapy. As the demand for expertise increases,
so do the risks of complications resulting from inexperience or
lack of understanding about both the nature of the condition
and the treatment modality. The NTI is easy to use but the therapeutic
protocol must be followed to attain optimal treatment
results. This means properly customizing the device to guarantee
posterior and canine disclusion, adequate retention and
proper vertical dimension.
Some claim that an NTI is simply an anterior deprogrammer
and you're using some savvy marketing
to rake in the dough. How do you respond?
Boyd: Use of a "deprogrammer" stipulates that lateral pterygoids
are "programmed" to prevent certain occluding contacts
from occurring during mastication. The practitioner employs
the deprogrammer in a chairside setting, which is nothing like
what happens during sleep. Comparing the NTI therapeutic
protocol to traditional deprogrammers or full-arch occlusal
guards doesn't make sense. By ensuring constant cuspid and posterior
disclusion, the NTI, an enhanced deprogrammer, minimizes
muscle intensity by as much as 70 percent and reduces
joint load during nocturnal parafunction. Other anterior deprogrammers
may allow posterior or canine occlusion and not only
allow, but may increase muscle activity and intensity.
What research is available to prove the efficacy
of the NTI as a migraine preventive treatment?
Blumenfeld: The standard used in medical practices in assessing
the effect of migraine prevention drugs is that they should ideally
reduce migraine frequency by at least 50 percent in at least 50
percent of the subjects. This usually involves comparing the active
medication to a placebo and showing superior effects. Unlike
drug trials, it is impossible to compare an intraoral device to a
placebo intraoral device, as anything placed within the mouth
elicits trigeminal sensory input. When compared to a "control"
mouthpiece, the studies done to date show that the NTI reduced
migraine events by 77 percent in 82 percent of the subjects.
If the NTI is effective, why hasn't the medical
community embraced it?
Blumenfeld: Just as it is in dentistry, a physician will prescribe
what he is familiar with. In addition, migraines remain
underdiagnosed and undertreated in medical practices. The
migraine specialist's goal for prevention is to eliminate or minimize
as much noxious sensory input as possible, and a properly
provided NTI does just that. However, most physicians are yet to
understand it that way. We believe that our next study will help
to expand the understanding of how the NTI affects migraines.
Aren't migraines caused by triggers like diet and
Blumenfeld: Almost… the term "trigger" is correct, but
"cause" is not. Trigeminal sensory dysmodulation is what allows
something that would otherwise be "normal" input to activate a
cascade of events that result in migraine pain. The less noxious
bombardment the sensory nucleus is exposed to, the less likely
the patient is to experience a migraine due to their "triggers."
To learn more about the NTI-tss therapeutic protocol, visit:
(Chairside Direct) www.nti-tss.com or (Lab Fabricated NTI Plus)