Dr. William L. Balanoff Has Over 30 Years Of Experience In Dental Orthotic Design, Research And Implementation.

The Journey to Research the TAG Appliance

A dental lab might be the last place you would ever think of when it comes to researching possible treatments for Tourette’s Syndrome. As the owner of a dental lab I certainly did not think it was a possibility.  

I’m Dr. Balanoff and I learned about an oral appliance that may help minimize the motor and vocal tics associated with Tourette Syndrome (TS).  Not really knowing a lot about TS, I absolutely didn’t believe that it was even possible to help with an oral appliance! Making it my mission to prove that an oral appliance could not help TS patients was my goal. It was disingenuous and unprofessional to give patients hope without published, peer reviewed science to support the claims. General dentists should not be diagnosing and treating Tourette Syndrome patients without proper research evidence to back them up.   

We dentists needed a study to prove an oral appliance has some benefit before prescribing to a tourette syndrome family.  As luck would have it, earlier in my professional life, I decided to get a postdoctoral master’s degree in Craniofacial Research.  I never thought that a degree with that limited scope would launch me on a trajectory that would impact so many lives.

Figuring out how to properly research

Designing a research project is easy in some ways and difficult in other ways.

The first thing was to really learn about Tourette Syndrome.  To accomplish this I wanted answers to the following 14 questions about this condition.

  • What is Tourette’s Syndrome?  
  • What causes TS?  
  • Is it Genetic, Viral, Bacterial or Contagious?
  • How is it currently treated?  
  • Is there a cure?
  • Are there supporting organizations?
  • Who does it affect?
  • How is it diagnosed?  
  • How is TS currently managed?  
  • Is there funding available for research?  
  • What studies have been published?  
  • Who were the experts? 

All the standard pre-research questions one needs to know before starting a journey of scientific discovery.  This is what I learned.

What is Tourette’s Syndrome?

TS is a neuropsychiatric disorder. 

What causes TS?

Tourette Syndrome is passed from parent to child genetically.  

Is the disorder Genetic, Viral, Bacterial or Contagious?

TS is genetic. But it is not viral, bacterial or contagious. 

How is it currently treated? 

Research is ongoing to understand the genetic component.  The most common treatments are pharmaceutical.

Is Tourette’s curable?

There is currently no cure. Symptoms can lessen or completely disappear over time for some patients. 

Are there supporting organizations?

The Tourette Association of America is the supporting advocacy organization with many other international and local organizations as well.

Who does it affect?

Mostly the young.  TS affects more boys than girls.  TS usually manifests itself around age 5-6 and decreases in 50% of the patients after puberty. 

How is it diagnosed?  

Tourette’s disorder is typically diagnosed by a neurologist or psychiatrist. There is not a medical test or blood test.  A clinical exam is performed based on behavioral history. Treatment specialists must have a history of tics in their patients for at least a year before giving a diagnosis of Tourette Syndrome.

How is TS currently managed?  

Management of Tourette Syndrome is difficult. Typically with drugs that not only suppress the tics, but also suppress the entire neurological system. The side effects include weight gain and depression.

Is there funding available for research?

There is only limited funding for TS research.  Even though TS has a devastating effect on the children and the families of the child, there is little financial help available.

What studies has been published?

There are many published peer reviewed articles by lots of experts worldwide.  The New Jersey Center for Tourette syndrome and the Tourette Association of America have been great advocates for Tourette Research. These organizations help support the families of children with TS.

Who were the experts?

Cornell, Yale and Rutgers University have been the leaders in Tourette Research and Advocacy.  There are many other universities and organizations in the US and throughout the world that have helped advance the knowledge of Tourette Syndrome.  Advancements include basic science and understanding to developing new clinical therapies.

Understanding where to start from is extremely important. Knowledge of the research that came before, the current outlooks and key influencers allowed me to take the first steps in dentistry.

Getting Involved as a Dentist

So how does a Dentist who founded a teeth whitening company get involved in what is commonly thought of as a medical or neurological problem?

Medicine in the United States is very specialized.  There is a specialist for every part of the human body.  I should know since I specialize in the mouth. What we have to remember though is everything in connected.  

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. 

Part of head and neck anatomy involves the nerves that control everything in the head and neck region.  These are called cranial nerves. Cranial nerves leave and return from the portion of the brain called the brain stem.  From an evolutionary standpoint, the brain stem is one of the oldest parts of the brain.  

As luck would have it, one specific branch of the Vth (5th) cranial nerve is called the Auriculotemporal Nerve.  This nerve leaves the brain stem and terminates in the thalamus.  

Why is this important?  The thalamus is the motor processing portion of the brain and processes the nerve signal that makes muscles move.  If you can stop this signal leaving the thalamus then you should be able to mitigate (stop or reduce) what it does.

A signal coming into the brain/thalamus area via the auriculotemporal nerve overrides a motor signal leaving the brain.  The patient tics less…or at least has a chance to tic less.

Learning about TS was an amazing process.  Now that I could see the potential for a connection from the mouth to the thalamus,  a proper research project could be designed.

Designing A Research Project

When designing a research project you try to prove the opposite of what you think to be true.  

If you can prove that something CAN’T happen then the only conclusion is that something other than that can happen.  

This may sound counterintuitive but that is the way of research.  The research design attempted to prove that any type of oral appliance would reduce motor and vocal tics by tricking the body by placing something in the mouth.  

The idea is called sensory deception.  If something is placed in the mouth, then the feeling of something in the mouth causes the brain to focus on the appliance in the mouth resulting in the brain’s ability to generate the urge to tic.

The research project would have 65 participants being treated in two different locations.  Different locations were chosen to minimize the claim that a particular doctor in a particular location only has the ability to treat patients in the study.  

The research design would test the patient in three ways:

  • The patient at rest with no appliance 
  • The patient with a typical occlusal/grinding guard and a 
  • The patient with a specially designed oral appliance.

What were we targeting with this research design?

If the results indicated NO difference when wearing either appliance compared to wearing no appliance then the study would show that a dental appliance has no measurable effect on Tourette Syndrome. 

If the results showed that there was NO difference between the typical dental appliance and the specially designed dental  appliance then the “special” appliance was not really special. The results would show that ANY appliance would reduce the frequency and intensity of motor and vocal tics.

What were the results?

We showed that a specially designed appliance for a TS patient was statistically reducing the motor and vocal tics associated with Tourette’s disorder. 

In fact, the results were statistically significant and clinically relevant.  Those two things are an important fact in any research study. 

Sometimes a study can prove something so small and insignificant, that from a “science” standpoint, the study was a success. Unfortunately, this has no significant or meaningful impact for patients.  

This study showed that not only does the appliance statistically help patients, but the clinical result is so obvious that a patient and their doctor can see the results immediately.  

The results are not some miniscule sub-clinical help…the results demonstrate a 40% reduction in the frequency and intensity of BOTH motor and vocal tics.  

The outcome were stunning to me.  Originally we were trying to prove that an intra-oral dental appliance would not have a measurable, clinically proven benefit. Now our data was showing the opposite.  Results of this magnitude needed to be shared and published.

Getting the Research Published

Sharing and publishing this positive outcome could benefit those dealing with TS, but scientists and academics are always trying to get published.  The task would be difficult. Why?  

When scientists want to publish research we are asking peers to validate and confirm what has been done.  That is the typical and correct reason for requesting publication. Other’s want to publish so that they can get credit “first” for what was discovered or reported.  

This Tourette’s Syndrome study just wanted to help us understand what, if anything, was going on with the jaw / TS connection.  Once the results were reported we knew we could help an underserved population of patients learn more if published.

The motivation was simple.  Results from the study should be published so that other scientists and treating doctors or dentists could share what was learned with their patients.  Furthermore, publishing provides patients the opportunity to find out about additional treatments for the clinical manifestations of Tourette Syndrome.

“I truly could not imagine keeping the results secret…that would be terrible”  

Dr Balanoff

By publishing the successful outcome of the study we allow clinicians and patients an alternative relief for symptoms of Tourette’s Syndrome.

Publishing a research article has to be understood for what it truly means.  For example, in our study we reported a 40% reduction in both motor and vocal tics, but what does that really mean?  

It means that when you add up the treatment results of the 65 TS patients that participated in the study and divide the results by 65, you end up with a result of 40% reduction in tics.  Some patients had a 5% reduction in tics and some patients that had a 95% reduction in tics.  

Most importantly however was that all patients showed some improvement. On average there was an overall 40% reduction in both motor and vocal tics.

Unfortunately, some others or those in the media will cherry pick a small portion, a line or two, from a published article to represent the total outcome.  It is certainly disingenuous to report in that fashion. 

Why was study size of 65 participants chosen?  

In research you are trying to prove that by adding a variable or something new to a group of “like” patients that the “ change” was the thing that altered the entire group.  We want to prove that the change was not due to chance but that the change was caused by what was new to the group. 

So, we take a group of patients (65) with mild or moderate TS.  Then we introduce something new into their lives and ask did that “new thing” help, hurt or have no effect on the symptoms of TS.  We are looking for statistical significance. 

What is statistical significance? In the world of research, if the experiment is done 100 times we would get the SAME results at least 95 out of 100 times.  The confidence of being right 95% of the time (whether trying to prove or disprove something) is what we want when conducting a study.  

The Tourette’s Research study had a 95% confidence level.  That is a big deal. Our study proved with statistical confidence and significance that if you repeated the study 100 times you would get an overall 40% reduction in motor and vocal tics 95 out of 100 times that experiment would be performed.

Another important aspect in research is clinical application or relevance.  Imagine doing an experiment and the results demonstrate the success statistically but the improvement was so negligible (small) clinically that the patient or a doctor could NOT really see any improvement.  

We then ask, “Is the treatment worth it to the patient or the doctor administering it if the improvement results are subclinical or unrecognisable?”.  The answer is probably not. Conversely, the TS study had an average of 40% reduction in symptoms. This makes it clinically relevant and the treatment is worth the effort.

That is to say, you can actually see amazing results using the TAG device for the treatment and mitigation of the motor and vocal tics associated with TS and Chronic Tic Disorder.  While this is NOT A CURE it can offer some relief.  

The study provided the combination of both statistical significance and clinical relevance necessary for peer reviewed journal publication.

What is a Peer Reviewed Journal and is it important?

A peer in the medical/dental world  is someone with the same educational background.  In the scientific world there are lots of professionals with PhDs, DDSs, or MDs who are brilliant.  Unfortunately, they don’t really have the ability to judge someone’s work unless the work is in a similar field.  

This is common sense.  As a prosthodontist, I am an expert when it comes to teeth, the mouth and craniofacial research than say a dermatologist.  While we both learned about dermatology and dentistry in school, neither professional knows enough about the other’s field to judge the work of the other.

When a research scientist submits the work to a peer reviewed journal, the research scientist is asking the journal to make sure that what is written is truly correct.  The scientific journal reaches out to other “like trained professionals” who have the educational background to decide whether or not what was submitted is true and correct.  The whole purpose is to protect the public and keep the published science true and correct.

The process is lengthy.  The statistics need to be checked by an expert in statistics.  The research design needs to be confirmed by “peers” who have participated in or have designed similar studies.  

Finally, the written word needs to be reviewed by other “peers” to make sure the science reads well, the results are true, correct and any claims that are made are definitely warranted and not exaggerated.

Once the entire process is complete, then and only then will the research paper be published. The lengthy publishing  process typically takes one year for a research paper to be published in a peer reviewed journal.

Where was it published?

https://www.aegisdentalnetwork.com/cced/2019/01/improved-yale-total-tic-severity-score-due-to-craniofacial-manipulation-with-an-oral-appliance

Improved Yale Total Tic Severity Score Due to Craniofacial Manipulation With an Oral Appliance Tourette syndrome and chronic tic disorders are increasingly recognized among school-aged children. These conditions are characterized by the presence of involuntary and repetitive vocalization and/or movement, known as tics, the onset of which can be spontaneous or may be preceded by premonitory urge. This study evaluated a novel treatment approach using the concept of cranial facial manipulation with an oral appliance known as the Tic Guard to determine its safety and efficacy in the treatment of these disorders. 

Amazing developments, but what’s next?  

All of the research and intellectual property was turned over to the Tourette Association of America.  The hope is that they carry on with the preliminary research and build upon this bright spot in Tourette Syndrome research.

In the meantime, we continue working with other dentists all over the world.  We provide help by teaching them to treat their patients. 

This allows some of those suffering with the effects of TS to get relief in a safe and reversible way. 

Any licensed dentists can prescribe the TAG (Tic Active Guard) appliance. The appliance is not FDA cleared because more research is required, but initial results show a dental appliance offers benefits. 

Doctors are never charged for my clinical time or the continuing education they receive when prescribing a TAG appliance. 

The Journey Continues…

In the beginning I started out to help patients with Tourette’s Syndrome by disproving all the anecdotal “fly-by-night” dentists wrong.  I believed, and still believe, that offering patients hope without proper research and proof is unacceptable.

This lead to us designing a research study that would be highly critical of the claims being made.  

We thought some small insignificant results may be found but nothing that would be statistically significant.  This is where we were proven wrong. The outcome exceeded expectations.  

My original disbelief in an appliance evolved into a drive to share this information with others in dentistry.  Research of this magnitude needed to be published. 

The research was published in the peer-reviewed dental journal Compendium in January 2019. This publication allows my follow dentists to discover and learn more about helping their patients with Tourette’s Syndrome.

Beyond the research and publication we continue to fabricate the TAG appliance under my supervision and license at our dental lab.  Dentists can contact us as needed for assistance helping their patients. 

We also try to let the world know about the research and potential benefits through our Dental based YouTube Channel.

Check-out the latest video that was made by two students who found-out about the TAG appliance and wanted to help.

If I have the knowledge to help patients have a better quality of life than I should share that knowledge with the world.  I am always available by phone. My personal cell number is 954-683-2693

Author: William L Balanoff DDS, MS, FICD

Dr. William L. Balanoff graduated from Northwestern University and received a postdoctoral masters in cranio-facial research from Nova Southeastern University. Dr. Balanoff practiced clinical dentistry for 30 years. He was on staff at two hospitals in South Florida. Dr. Balanoff has taught at numerous academic institutions worldwide. Dr. Balanoff is published and sits on two different peer reviewed journal editorial boards both in dentistry and medicine. Dr. Balanoff has testified before the US Congress and helped craft public policy initiatives in the US as well as Russia, the Ukraine, Belorussia, Japan, Spain and England. Dr. Balanoff holds a number of patents for unique medical devices. Currently Dr. Balanoff is a science consultant for Abova Health and is the CEO of Oral Care Perfected. Dr. Balanoff has appeared on the CBS show “The Doctors” for his groundbreaking research with respect to an oral appliance mitigating the motor and vocal tics associated with Tourette Syndrome.