By Jason Tierney
What goes bump in the night can result in significant pain in the daytime. New research has been published demonstrating the effectiveness of the Nociceptive Trigeminal Inhibition Tension Suppression System, or NTI-tss Plus, in significantly reducing medically diagnosed migraine pain. The device is worn during sleep and typically covers the anterior teeth, although it can be extended over the entire dental arch. The proprietary design e is one of my favorite title chops it’s the first wave so often becomes one of the more I am using one of The Replacements kiss me and how it usually turns up is it the chopped on your endnsures canine and posterior disclusion in a centric clench and all excursive bruxing movements. This has been shown to reduce clenching intensity by 70%, which may reduce headache and migraine pain and frequency.
BMC Neurology published the results of a paper titled “Adjunctive treatment of chronic migraine using an oral dental device: overview and results of a randomized placebo-controlled crossover study.” Authored by Andrew M. Blumenfeld, MD and James P. Boyd, DDS, the placebo-controlled crossover pilot study was conducted with IRB oversight to assess the efficacy of the NTI splint compared to placebo using changes in the Headache Impact Test (HIT-6) score as the outcome measure. The HIT-6 score is a meaningful measurement because it accounts for both the severity of pain and the adverse impact on the migraineur’s quality of life (QOL).
Nineteen refractory Chronic Migraine subjects completed baseline HIT-6 questionnaires. Each subject was provided with an NTI splint or a placebo splint for 30 nights of use. After completing the 30-night period, the subjects switched to the alternate device for an additional 30 nights. Upon completion, the subjects completed a final HIT-6 questionnaire.
The initial baseline average HIT-6 score for all subjects was “Category 4: Severe impact, disabling pain.” The study’s results showed that 68% of the patients had at least a one-category improvement with the NTI device compared to only 12% when using the placebo.
36% of subjects experienced a two-category improvement when using the NTI. Compare this to 0% that experienced a multiple category improvement with the placebo splint. Additionally, no adverse effects were reported by any of the subjects or observed by the clinicians.
This landmark study reinforces findings in a previous study submitted for FDA clearance. That study compared the NTI with a traditional full-arch dental splint as the control. Nearly as many subjects using the control splint reported worsening symptoms as those that reported improvements. Compare this to the subjects who used NTI devices. 82% of the NTI subjects experienced a 77% reduction in migraine events.
Barry Glassman, DMD, author of numerous papers on the topic of splint therapy for pain management, stated, “In 1960 Berlin and Dessner reported 87% success in the treatment of primary headaches with the use of an anterior contact bruxism appliance. More recent work continues to demonstrate that the NTI, using an improved therapeutic protocol, is an effective
preventative having a significant effect on the quality of life of migraineurs without the potential untoward side effects of pharmacotherapy.”
In 2011 Inside Dentistry published “Patterns of Use for an Enhanced Nociceptive Trigeminal Inhibitory Splint” authored by Andrew Blumenfeld, MD; Steven D. Bender, DDS; Barry Glassman, DMD; and Andres Pinto, DMD, MPH. More than 500 dentists responsible for prescribing over 78,000 NTI devices rated the therapy as 96% “Mostly Successful” or “All Problems Resolved” for headache and migraine pain. They noted the incidence of any side effects to be less than 2%.
The paper’s authors – a dentist and a neurologist – conclude that the NTI has not yet reached an inflection point in clinical adoption. They note, “The reasons for this may include prior experiences of patients with negative outcome from traditional dental splints and a lack of knowledge…” among dentists regarding the proper indications for using an NTI device.
NTI-tss Plus devices should only be prescribed by knowledgeable dentists using NTI-certified dental laboratories. For additional information about the NTI, contact Transform Dental Sleep.
Jason Tierney is a reading, writing, running, critical thinking contrarian. He’s spent over 15 years focused on developing products and business solutions for the fields of dental sleep medicine and parafunctional control.