In 2016, celebrity dentist and occasional SBM contributor Grant Ritchey and I wrote a post on claims involving the potential use of a dental appliance for the treatment of tics caused by Tourette syndrome, a complex and fascinating neurological condition that I also happen to have. At the time, we were quite skeptical:

In summary, while we can’t yet discount the possibility that a dental appliance, be it a Neurocranial Vertical Distractor or a TicTocStop appliance, can lessen or eliminate the tics that Tourette syndrome patients have, we can conclude that the biological plausibility for such a device is very low. What we know about TS doesn’t jibe with dental hypotheses. YouTube videos and testimonials, as impressive as they may seem, are insufficient because the natural course of TS and the role stress/placebo plays can make absolutely any intervention (and in particular for neurological problems) seem to work in the short run. And the literature on the subject has essentially been a monopoly by two dentists who treat Tourette patients and is scant and of low quality.

Ultimately, readers will need to decide if this is an extraordinary claim or if repositioning of the jaw in an effort to reduce the neuromuscular manifestations of this complex disorder is in line with our basic scientific understanding of neuroanatomy and the consensus pathophysiology of TS. Once a sense of the prior plausibility is determined, the degree of evidence required to make a causal claim can be decided. Then a provisional conclusion can be made that may or may not change if new data is actually published.

At this point, we would caution anyone who has TS, or is the caregiver of someone with the condition, to be wary of these claims until the science can better support it.

In our initial post, we mentioned that a proper study was being planned under the guidance of Timothy Hottel, the Dean of the College of Dentistry at the University of Tennessee. This study was funded by a $350,000 donation from Tic Toc Stop Inc., a charitable organization founded by radio personality Craig Carton. Carton, and Tic Toc Stop Chief Medical Director William Balanoff, heavily promoted (here on The Doctors in 2016) the study, which as described did not inspire confidence. But we remained hopeful.

A little over a year later, Grant, who at the time was heavily involved in coronavirus gain-of-function research in his basement virology lab, corresponded with Dean Hottel and Dentist Balanoff. We were delighted to learn that the study had been completed and was in preparation for peer review and imminent publication. “Huzzah!”, Grant exclaimed. Unfortunately, Grant’s excitement was premature.

Nearly two years after our original post, we revisited this topic in a May 2018 SBM post because the study had yet to be published and there were some interesting developments behind the scenes. Carton, essentially the money behind the study, had been arrested in September of 2017 on criminal charges of securities fraud and wire fraud, as well as conspiracy to commit those crimes. There were also serious allegations that the Tic Toc Stop foundation didn’t actually do anything to help people with Tourette syndrome.

Grant, I assume using a quill and some parchment paper (because he is very old), had again contacted Hottel and Balanoff. And again, we were reassured. The study had been submitted for publication, though they didn’t reveal to which journal. Balanoff even promised to give us a heads-up just as soon as it was officially accepted. Grant was practically giddy and needed a few extra minutes of nitrous oxide before he could fall asleep that night.

We also wrote at the time that there appeared to have been some kind of upheaval in the University of Tennessee College of Dentistry involving Dean Hottel being placed on “indefinite suspension”. This ended up being a false alarm based on oddly worded minutes from a board meeting. Dean Hottel was simply replaced because he took a position as Director of Statewide Oral Health Initiatives for the University of Tennessee Health Sciences Center.

We noted another interesting tidbit at the time:

But the really interesting thing is that just as we were writing this post Dr. Balanoff took down all of his references of and associations with Tic Toc Stop as well as the outline of his study design. On his new website (he kept the same URL), he is now promoting an appliance for TS called the T.A.G. appliance. Our hunch is that it is the same appliance as before, but just rebranded. He will probably still use the same shoddy study he has been conducting for years to promote his gadget to dentists, dental labs, and vulnerable people with TS.

So here we are in these uncertain times of 2022. Was a study on the use of a dental appliance for the treatment of Tourette syndrome ever published? Or had this merely been a marketing stunt? Grant and I had initially been hopeful, but with the lead researcher at the University of Tennessee’s College of Dentistry leaving his position, the main promoter and money man facing a lengthy prison sentence, and the brains behind the study ghosting the whole operation, we had pretty much given up.

I can’t speak for Grant, but I will readily admit that I put no effort into following up on this over the past 4 years. I honestly never expected this study to see the light of day. I was wrong.

Earlier this week, when looking into similar claims involving a magic wrist buzzer being used to treat Tourette syndrome, I remembered the Tic Toc Stop fiasco and found that the study was actually published in January of 2019 in Compendium of Continuing Education in Dentistry. I’ll briefly break down the study and why it is essentially worthless, as we expected it would be. Better late than never, I suppose.

Improved Yale total tic severity score due to craniofacial manipulation with an oral appliance

In our original post back in 2016, Grant discussed the historical underpinnings of these claims, so I won’t go into detail here. Needless to say, the proposed mechanism given in this study is garbage:

Thus, the action of separating the posterior opposing teeth (typically in excess of 4 mm to 5 mm) causes the condyle to rotate within the condylar fossa of the TMJ and translate down the articulate eminence of the temporal bone. Opening the bite in this way creates neurostimulation of the sensory fibers of the joint capsule to create a shutoff mechanism in the brain to prevent the motor nerves from leaving the brain to fire. The signal received by the brain via the Vth cranial nerve reduces or eliminates the motor signal from the brain to the III, IV, V, VI, VII, IX, and XI cranial nerves.

No evidence exists to support the existence of this “shutoff mechanism”. I could just as easily claim that it actually causes a “boosting mechanism” or, more likely, there is no spoon…I mean mechanism. The mechanism proposed in the study is a bit broader than the claims we addressed back in 2016, specifically because they mention cranial nerves other than just the trigeminal (V). We have the pathways involved in TS fairly mapped out, and though we don’t know everything, this just makes no sense and my earlier response still holds up:

  1. Tics are present in virtually all muscle groups, not just the muscles of biting and chewing. Why assume that the trigeminal nerve is the culprit? Many assumptions must be made to connect the trigeminal nerve to blinking, let alone shoulder shrugging and coprolalia that don’t make any sense neurologically.
  2. How does trigeminal “overstimulation” lead to the changes in the brain neuroanatomy seen with advanced imaging, or are those a coincidence? To our knowledge, there are no other medical conditions with a similar pathophysiology. There already is a condition involving chronic injury of the trigeminal nerve called trigeminal neuralgia, however, and it causes severe facial pain but no other neurologic symptoms.
  3. Assuming “overstimulation” of the trigeminal nerve can result in neurological symptoms, why does it selectively cause tics, ADHD, and OCD and not seizures, schizophrenia, personality changes, or some other neurologic problem? What explains the urge to tic?
  4. Why is there a clear genetic pattern to TS? TMD does not run in families to anywhere near that degree.
  5. How does TMD as a factor explain the waxing and waning course of TS and the fact that most patients have significant improvement after puberty? Does malposition of the jaw improve after puberty and as patients age?

The study design, as I mentioned above, renders the result practically meaningless. They did not, as would be necessary to provide any helpful data, randomize the 67 subjects into treatment and control arms with a well thought out sham device. As I’ve explained many times in previous posts, tics associated with Tourette syndrome are significantly affected by environmental and psychological variables. They are highly susceptible to placebo. This is why there are countless examples of various bogus interventions seemingly providing an instant cure.

In the study, they obtained a patient-reported baseline tic severity score and then each subject underwent dental imaging and measurements for a custom oral appliance (Tic Guard). They were then each given a standard mouth guard orthotic. They knew it was a standard mouth guard. There was no blinding.

Tic severity was assessed after a week of wearing the standard mouth guard and then subjects were given their Tic Guard. Again, each subject knew that they were being given a specially-made device. Nobody was blinded. They were almost certainly told that the Tic Guard had already been found effective in “pilot studies” or at the very least had been exposed to the “miraculous” videos where children have dramatic improvements of their tics. There is nothing in the paper that contradicts this assumption.

Tic severity was again assessed one week after subjects were given their custom-made Tic Guard and then again ten weeks later. The study subjects, 3/4 of which were male and the average age was 15 years, were not required to keep a log of how much they wore their Tic Guard. They were just asked at the end. There is no way to now how much they used the devices or even if they did at all. This may come as a surprise, but teenagers (all humans actually) sometimes just tell people in positions of authority what they think they want to hear.

The study found exactly what I would have expected. After a week of using (or not using) a standard mouth guard, subjective tic severity scores were improved when subjects were interviewed by personnel involved with the study. On average, there was a roughly 16% improvement in total tic severity compared to baseline scores at that point.

This doesn’t mean that the standard mouth guard worked. It also doesn’t mean that there was some kind of magical “mind over matter” placebo effect. It means that people in studies who know that they are in studies, who want to improve, who want to please investigators or caregivers, and who are asked to self-report their recall of how they are doing, tend to report that the are doing a bit better. This improvement would have likely been seen even without being asked to wear the standard mouth guard.

After a week of using (nor not using) the custom-made Tic Guard, subjects self-reported an additional 5% improvement, which was deemed to be statistically significant by the study authors. At the final assessment ten weeks later, subjects self-reported an additional 14% improvement in total tic severity. During this time, 9 of the 67 subjects didn’t return to be assessed. We don’t know why 14% of subjects dropped out, but it is certainly possible that this would have made the final numbers look very different.

The authors conclude that both the sham mouth guard and the Tic Guard work, but the Tic Guard works better. A more accurate conclusion is that teenagers with Tourette syndrome are likely to report that their tics are partially improved when they are enrolled in a poorly-designed study, and more so when they are told that an intervention works. There was no effort in this study to actually control for placebo effects.

The authors’ cherry on top:

This study clearly demonstrated that tics in all test subjects were mitigated by optimizing the opening of the vertical dimension. Understanding where the condyle is in relationship to the articulate eminence and fossa will provide guidance as to “why” this works effectively. The long-term implications outpace this study design. Perhaps a treatment modality would be craniofacial surgery to correct a maxilla/mandibular discrepancy. Possibly, interceptive orthodontics might be appropriate on patients with a family history of TS and a propensity toward a class II occlusion; this would be a patient population that would require early screening and treatment.

Research should ideally prove that there is an effect before we talk about how to optimize the proposed underlying mechanism for it. And yes, the authors are throwing out the possibility of surgical intervention and even having kids use Tic Guard oral appliances to potentially prevent the development of Tourette syndrome. Nope.

Tourette syndrome is much more than just a collection of tics. The plausibility that an oral appliance plays any role whatsoever in the pathophysiology that results in tics, however, is extremely low. The evidence in support of such a dental device as a treatment would need to be quite robust in order to warrant acceptance. This ain’t it.

Where are they now?

Tim Hottel is currently an adjunct professor at Lincoln Memorial University and does not appear to be involved in any additional research into dental treatments for neurological conditions. It remains a mystery as to why a respected Dean at a major university would have ever become involved with such a ridiculous study. I don’t think we will ever know what might have been going on behind the scenes.

After his arrest in late 2017, Craig Carton would ultimately be sentenced to 3.5 years in prison and ordered to make restitution of $4.8 million. As of August 2022, he has completed his sentence and is again working very successfully as a radio and television personality. He does not appear to be doing any advocacy or fundraising for Tourette syndrome and the Tic Toc Stop foundation no longer exists. The only person that I can find still touting the device, though under a different name, is William Balanoff.

Balanoff posted a lengthy explanation of this study on his website that is full of nonsense like the following, worthy of it’s own SBM post:

In particular the jaw to brain connection is complex and can have an affect on other parts of our anatomy. Since dentists are experts in head and neck anatomy they are the best qualified to analyze the data provided from research study.

Grant Ritchey continues to practice as a dentist, I think in Nebraska, and has two cats that are both named Gary. He is a smart guy, and has never murdered any lions that I am aware of, so I would love to get his take on whether or not dental school prepared him to evaluate neurological conditions and brain anatomy. I would weigh in myself, but I think I’ve already overstayed my welcome a bit when it comes to this particular issue, and I don’t want to come across as a rabid anti-dentite.

Author

  • Clay Jones, M.D. is a pediatrician and a regular contributor to the Science-Based Medicine blog. He primarily cares for healthy newborns and hospitalized children, and devotes his full time to educating pediatric residents and medical students. Dr. Jones first became aware of and interested in the incursion of pseudoscience into his chosen profession while completing his pediatric residency at Vanderbilt Children’s Hospital a decade ago. He has since focused his efforts on teaching the application of critical thinking and scientific skepticism to the practice of pediatric medicine. Dr. Jones has no conflicts of interest to disclose and no ties to the pharmaceutical industry. He can be found on Twitter as @SBMPediatrics and is the co-host of The Prism Podcast with fellow SBM contributor Grant Ritchey. The comments expressed by Dr. Jones are his own and do not represent the views or opinions of Newton-Wellesley Hospital or its administration.

Posted by Clay Jones

Clay Jones, M.D. is a pediatrician and a regular contributor to the Science-Based Medicine blog. He primarily cares for healthy newborns and hospitalized children, and devotes his full time to educating pediatric residents and medical students. Dr. Jones first became aware of and interested in the incursion of pseudoscience into his chosen profession while completing his pediatric residency at Vanderbilt Children’s Hospital a decade ago. He has since focused his efforts on teaching the application of critical thinking and scientific skepticism to the practice of pediatric medicine. Dr. Jones has no conflicts of interest to disclose and no ties to the pharmaceutical industry. He can be found on Twitter as @SBMPediatrics and is the co-host of The Prism Podcast with fellow SBM contributor Grant Ritchey. The comments expressed by Dr. Jones are his own and do not represent the views or opinions of Newton-Wellesley Hospital or its administration.