Corporate Profiles: Keller Labs

In 2001, the FDA granted marketing approval to the NTI-tss device for the prevention and treatment of certain migraine, tension-type headaches, and TMD by reducing neuromuscular activity as a result of its reduction of trigeminally innervated muscle activity. Since then the NTI-tss therapeutic protocol has gained in popularity. Based on sales and customer records, it appears that nearly 15,000 U.S. dentists now use the device on a monthly basis.

Yet, despite the 10+ years of NTI experience and growing popularity among clinicians, several concerns regarding its use have persisted, the most serious being fears that a patient might aspirate the device or that long term use of NTI might cause permanent “occlusal” changes, e.g., anterior open bite.

To help quantify these concerns an independent survey company conducted the NTI Patterns of Use Survey (2010) among current NTI providers. The 587 respondents, predominately general dentists, but including orthodontists, periodontists and prosthodontists, reported placing more than 75,000 NTI devices. Their responses provide valuable insight into the incidence of serious complications and the effectiveness of the device.

Author, researcher and Director of The Headache Center of Southern California, neurologist Andrew Blumenfeld, M.D., recently presented findings at the International Headache Society meeting in Nice, France. The abstract of Dr. Blumenfeld’s presentation is published in the Journal of Headache and Pain, and portions of his poster are featured in the figure below.
Is it effective?

“The NTI therapeutic protocol is the cornerstone of my practice because it can protect my dentistry while relieving patients’ painful symptoms, whether it’s sore muscles from clenching or in some cases, debilitating migraines due to nocturnal parafunction,” said Dr. Barry Glassman of the Allentown Pain Center. The survey’s results support Dr. Glassman’s claims. 96% of respondents ranked the NTI-tss as “completely successful” or “mostly successful” for treatment of pain “above the cheeks” while nearly 92% ranked it as “completely successful” or “mostly successful” for pain “below the cheeks.”

Concerns about adverse side effects
Of the more than 75,000 NTI’s accounted for in the survey, there were only three claims of aspiration and not one was confirmed radiographically. When asked if he had any concerns about aspiration, Dr. John Nosti of The Hornbrook Group Clinical Mastery Series said, “I’m aware of that myth but I think it needs to be busted. The NTI’s small size is actually an advantage. My patients that won’t tolerate a full-arch splint are almost always compliant with the NTI. They’re more comfortable with the device and actually wear it.”

The other commonly cited rationale for not using the NTI is a concern about development of an anterior open bite due to supraeruption of the posterior teeth. Dr. Charles Payet, a general practitioner in Charlotte, NC weighed in on the topic, “I do a lot of short-term ortho in my practice and if someone asked me to move a molar but I couldn’t place any brackets or force on it and could only have it out of occlusion while the patient slept, I’d say ‘no way, impossible.’ It’s the same principle with the NTI, the teeth contact normally when the splint is removed and any stimulation from normal function prevents tooth movement.” The survey’s results also debunked the anterior open bite myth with a reported incidence of a mere 1.6% and are actually attributable to condylar repositioning, not tooth movement.

After reviewing the survey’s results, Dr. Glassman concluded, “This confirms what I’ve observed over the past ten years of prescribing the NTI for thousands of patients. Unlike other splints that have been shown to actually increase parafunctional intensity in many cases, NTI therapy is effective for the treatment of pain, protection of teeth and restorations, and maybe most importantly, patients wear it. As dentists, we strive to treat our patients with the least invasive, most effective treatment modalities available. That is why the NTI-tss should be the standard of care in every practice.