NTI-TSS.com - The most effective FDA-approved method of migraine prevention

     Prior to the FDA approving the NTI for prevention of medically diagnosed migraine, it was approved for the prevention of temporomandibular disorders.  At the time, the migraine prevention clinical trials were underway (and the "NTI" name had already been adopted).  Prior to the NTI being approved for migraine prevention, NTI-TSS, Inc. was restricted by federal regulations from making any claim regarding migraine prevention (so NTI-TSS Inc. could not publicly explain why the term "NTI" was being used). 

     Although a daytime device is not usually necessary when treating TMD with an NTI (the absence of posterior and canine contacts during sleep keeps the elevator muscles from contracting with maximal intensity, thereby preventing the lateral pterygoids from contracting with any resistance, thus eliminating the method of joint strain and damage), experts could only assume that the NTI was identical to the typical "anterior deprogrammer", a device used in a chairside setting, whose intent is to "relax" elevator muscular by limiting contact to the incisors.  

     So although it is true, that the "reflexes" exploited by incisor contact by an anterior deprogrammer are (probably) not present during sleep, the therepeutic effect of the NTI results from the prevention of posterior or canine contact, thereby preventing massive noxious trigeminal sensory input (nociception)

     This claim is usually made without any supportive literature or experience.  The "anterior splints" referred to are those such as an anterior bite plane (which includes a clenching surface for the opposing canines), or the traditional anterior bite stop / deprogrammer (click here for a demo of the difference).
    Experts making these claims clearly have not investigated the NTI protocol, or have any experience with its use.  For example, on lecturer reports in his presentations that "the NTI research" was not done while the patient was asleep.  His point is that after several weeks, nocturnal clenching intensity will return to its prior state (as he observes with a full-coverage splint), thus "causing" disc perforation due to lack of "posterior support". However, the method in which clenching intensity can return to normal is due to canine contact on the deprogrammer during an excursive movement.  Some lectureres mistakenly state that patients are able to overcome the inhibition reflex during sleep and clench with damaging forces on the anterior deprogrammer.  It is not the "inhibition reflex" during sleep that patient's overcome (it may not even be active during sleep), but the avoidance of canine and/or posterior occluding.  This concept is clearly stated on the NTI-tss main page  as well as the danger of allowing canine contact, especially in excursive movements when using a traditional deprogrammer therapeutically.         

NTI-TSS, Inc. is obligated to report any and all adverse results to the FDA so that the public (both the patients and dentists) can be fully informed of its limitations.  (Thus far, in over 1.5 million NTIs in use, a disk perforation has yet to be reported). Please report any such incidents to NTI-TSS, Inc. 

From a lecturer's handout:

     Also, from a typical lecture handout, it is stated: 
--"The small pea shaped, rounded, anterior splints have been known to fracture lower incisors when patients clench or brux during sleep."  (page 9, without references).  Again, without knowledge of appropriate NTI therapeutic protocol, this would be an casual conclusion if the practitioner had missed a posterior contact in excusrive movement, resulting in perpetuation of clenching intensity and sore (and possibly damaged) lower incisors.
But from the same handout:.
--"Parafunctional habits (clenching and bruxing) are the primary causes of TM disorders."
(which is the rationale for the NTI device protocol)
--"Make splints for all clenchers and bruxers after restorative treatment is completed to protect the restored crowns from wear and/or fracture." 
(Obviously then, if the occlusal scheme or skeletal relationship was the cause of TMD, ideal restorative treatment would not require any protection)

     The intent here is to lead one to believe that the teeth will drift or supraerupt due to NTI use.  Curiously, this claim is usually made by the same experts who promote the use of CR in full-mouth restorative cases.  Clearly, when the condyles are manipulated into CR, they sometimes tend to seat to a more superior and posterior position than their original orientation.  The result is obviously a change in the occlusion, that is, the opposing arches relate differently.  The teeth have not moved, although the scheme of occlusion has changed.
     By reducing the intensity of nocturnal parafunction, the NTI simply allows the condyle(s) to seat to their most superior musculoskeletally stable positions.  In some cases, this results in a change in the occlusal scheme.
To date, there is no reference to show that teeth move when out of occlusion during sleep and engaged in normal function throughout the day.

It's just a "speed bump".
     This is probably the most accurate.  The therapeutic goal of the NTI is to reduce the intensity of nocturnal muscular parafunction to asymptomatic levels.  This too, is the goal of a speed bump:  to reduce the speed of a vehicle in areas where intense speed is both unnecessary and dangerous.  However, the critics making this claim also state that the NTI is intended as the one-and-only therapy for a patient, and promote that the occlusion must be addressed, as well.  Nowhere in the NTI protocol is it suggested that following the reduction of signs and symptoms that no other therapy be provided.  Successful NTI protocol is frequently the initiation of comprehensive occlusal therapy, as interferences and appropriate condylar position present themselves.

HOWEVER, that does not imply that a dentist is not at risk of legal action from a patient, which is true of ANY service provided.  A dentist is obligated to provide a complete Informed Consent prior to the initiation of any therapy. 

     One TMD expert, distributes a "newsletter" to dentists in his surrounding area.  In his newsletter, he occasionally includes "information" regarding the NTI, titled "NTI --A potentially harmful device".  Although he had at one time agreed to discontinue the distribution of his NTI content, he continues to do so.  Some of the highlights:
--"It is nothing more that a simple anterior jig.  The only thing revolutionary about the NTI device is the marketing hype around it.  I have taught courses on the design and use of jigs for over 20 years"
   Sometimes, teachers need to take refresher courses, too.
-- "It can cause irreversible problems for the patient, and significant liabilities for the dentist".
   Prior to providing an NTI, the practitioner must be aware of the range of diagnostic revelations that an NTI can produce, and discuss these with the patient prior to initiation of therapy.  For example, if the practitioner ignores a patient's minimal incisal overlap (of say, 1mm), and NTI therapy results in a re-orientation of the condyles to a more superior position (CR), then the patient will most likely have developed an Anterior Open Bite.  Without addtional restorative or orthodontic intervention, this may remain as an irreversible change.  Regardless of the degree of therapeutic success (for example, migraine frequency dramatically reduced), the patient may claim negligence on the practitioner's part. 

( the original science behind the NTI from Dr. Okeson's text book)
  While lecturing in Australia, one lecturer was asked about the NTI:  "You have to read the research. Too often you dentists just read the synopsis that CRA says a product is good. You don't read the research and that's what I'm asking you to do. I'm not saying that the NTI doesn't work."
     At a subsequent lecture in Australia:  "You know you really must look at the research behind this product. You see, these guys came to me a few years ago because I think they wanted me to promote their product...I said that I needed to see research first....which they didn't have....so then when they got this FDA approval, I read the study, they were comparing their product to a bleaching splint NOT a TMJ splint. This was an incorrect comparison.  You guys really need to read what's in the research."

The research submitted to the FDA is clear.  The FDA simply requested that a "control" device be used to confirm the proposed hypothesis:  that a bleaching tray would have an effect on migraine (which it did as predicted).  Some patients had improvement, some did not, some got worse...all in the proportion predicted.  The NTI  reduced migraine attacks by 77% in 82% of sufferers within 8 weeks, as predicted to the FDA.  The sole intent of the study was not to "compare" to a TMD splint, but to establish whether or not it could be legitimately claimed that the NTI prevented migraine.  

Dr. Gregory Turek, an Australian dentist with considerable experience with the NTI, wrote to Amalgadent, who distributes the NTI in Australia, regarding this lecturer's comments:
      The presentation was very expert and impressive but the lecturer virtually omitted the key causal factor of most head and neck pain, jaw clenching. He briefly mentioned bruxism, saying its something everyone does and its normal but he also indicated that stress plays a part. He also indicated that malocclusion does not in itself cause TMD type pain, yet his standard treatment is a full coverage splint to establish, "stable occlusion", he also provides stress counselling and instructs patients to avoid teeth contacting during the day. This last instruction shows he understands the role of the proprioceptive clenching reflex and muscle stimulation, yet he makes a full coverage splint!  What about sleeping? Doesn't he realize his full coverage splint (with "slightly heavier posterior contacts") creates the potential for  greatly increased muscle stimulation?     Tests have shown that severe bruxers exert up to 14 times more bite force than non severe bruxers but this figure increases up to 20 times with a full arch splint.  I approached him after the lecture and suggested that he had underestimated the impact of of involuntary jaw clenching on TMD type pain. His answer was that by far the majority of studies had been carried out with full coverage splints and there was no evidence that involuntary clenching had any impact on TMD type pain. I was astounded by these comments.  Having made hundreds of carefully fitted, full coverage splints during my 30 year dental career with generally mediocre outcomes, then seeing astounding improvements using the NTI device, I wondered why he had not observed this also.    

     I have now fitted over 150 NTI devices and have been steadily evaluating them by way of patient questionaire sent 8 weeks after fitting. For common tension related head and neck pain the success rate (marked improvement) is at least  80%. With migraines the success rate is lower, but still better than anything else available and its drug free, non invasive !     I wear an NTI myself, so does my wife, 2 sisters(one a dentist), and many of my extended family also, they are the most critical patients I have, no complaints !     The principle behind the NTI is quite simple and obvious once you understand it. Nature gives us receptors (especially  under our molar and canine) teeth to help us chew food, so when we bite down on say a piece of meat, we stimulate these receptors which via the brain, tell our clenching muscles to work harder. In a normal relaxed person, teeth should only touch for eating, swallowing and speaking, at all other times our jaw should be suspended with teeth apart. When we experience stress, adrenaline and cortisol via the "fight and flight" mechanism, tighten our clenching muscles, bringing teeth closer together. During sleep and cycles of bruxism this is significantly intensified. How often have you heard someone sleeping nearby loudly grinding their teeth?     My petite wife makes sounds like a draft horse grinding up oats. What sort of load is this activity putting on the clenching muscles and head and neck musculature?The NTI effectively suppresses this activity with obvious benefits"   Regards, Greg.

     In order for the U.S. FDA to approve a medical device, the manufacturer must prove that the device is either the substantial equivalent to an indentical product that has the identical therapeutic modality (a "510(k)"), or, the manufacturer must provide new clinical data that substantiates the manufacturer's claims (a pre-market analysis "PMA")
     The NTI-tss had already been approved by the FDA for "the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity" prior to the submission for a marketing claim of "prevention of medically diagnosed migraine pain".   Since the NTI-tss would be augmenting its then current marketing claims, the submission of any new marketing claims was to fall under the 510(k) process.  However, this did not relieve the manufacturer (NTI-TSS, Inc.) from having to provide the clinical data to support its claims, as in the PMA submission.
     In order for a device or drug to be FDA approved for "the prevention of migraine", the device or drug must meet or surpass an efficacy threshold of "at least a 50% improvement for at least 50% of subjects", by either providing new data to prove such (PMA), or to show substantial equivance to a similar known product.  A full-coverage splint (which has been shown to reduce migraine attacks in at least 50% of subjects, although in some of the the <50% of those who did not improve, migraine frequence was increased) was used as a control device to compare to.  Therefore, the NTI device had to statistically show that it was "at least as good as" the control device, and show that at least 50% of subjects had at least a 50% improvement.
     Manufacturers are not obligated to submit their clinical trials in article form to health-care journals.  Whereas a journal may elect to publish interesting findings and outcomes, the FDA can only approve marketing claims of medical devices based on conclusive data.  In the clinical trials, 82% of subjects using the NTI device had a 77% average reduction in migraine events, and was statistically "as good as" the control device.  Following the submission of the clinical data to the FDA, the lead investigator of the trials submitted an artical to a health-care journal.

 The Swedish National Board of Health and Welfare's Division of Stomatognathic Physiology has advised Swedish dentists that based on the opinion of their appointed expert, Tomas Magunsson, DDS, if a patient were to have an unfavorable occlusal outcome and file a complaint with the government, the government may not be able to support the dentist.
     Dr. Magnusson's concern stemmed largely from his clinical observations of occasional presentations of an anterior open bite of patients referred to his clinic.  In some of those cases, it was observed that although the desired seating of the condyle to a more stable position had apparently occurred,  it didn't fully explain the maxillary plane of occlusion, particularly the anterior maxilla.  His hypothesis was that there had been varying degrees of intrusion of the anterior maxilla, either in whole or of only those teeth included within the NTI device.

     Dr. Magnusson's observations, as well as other significant contraindications for an upper device, has prompted NTI-TSS, Inc. to recommend a lower device as the default design of choice.  Although the pursuit of the desired result of reduction of parafunctional activity and subsequent seating of the condyles to their most stable position is unaffected (rather, it appears to be enhanced), it does reduce or eliminate the potential for rotation or intrusion of the anterior maxilla.

Steven Graf-Radford, DDS, claims he is "not crazy about the NTI" in this video commentary from from the educational site for medical practitioners: www.migraineresourcenetwork.com .

His specific concerns are addressed in this edited video from his commentary:

Aside from presenting unfounded claims and perpetuating physiologic mythology, this lecturer contradicts himself.

First, he seems surprised that a patient who is experiencing relief would continue to use their NTI device nightly, and then claims that patients who report to "pain clinics" with joint pain continue to use their anterior deprogrammer.