There at the Start: The First Years of Mandibular Advancement Devices

It was March 1985; I was at a dental meeting in Clearwater Florida, enjoying a warm weather respite from my home in Albuquerque. After a short run on the beach, I went to get a cup of coffee and found my colleagues talking about the term “sleep apnea.” Someone told an early morning joke and I missed the part about what sleep apnea was or why we were talking about it.
Two weeks later, a local otolaryngologist and I were driving our sons to Vail for a ski race that the boys had been invited to. For some reason the term sleep apnea popped into my head, so I asked him about it. He had very limited knowledge of sleep apnea, however he recalled a recent article from two DDS/MD’s at Stanford that he would send me. He also knew of someone at University of New Mexico Medical School interested in this area. Approximately one week later, I received the article concerning surgical repositioning of the mandible and the name of Dr. Wolfgang Schmidt-Nowara [WSN].
This got me thinking about other ways to open the airway, because many people didn’t want to have invasive, expensive surgery. I knew about Bionators and other orthodontic devices used to hold the jaw forward, so by May of 1985, I had developed a plan for an acrylic appliance, and I just needed some patients. I tried to contact Dr. Schmidt-Nowara several times – he finally agreed to 15 minutes in November late in the day to meet. He was really not interested in my plan until I told him I was not going to charge the patients anything for the 8-10 hours each device would take for me to position and fabricate the appliance. He agreed to send some patients.
Fabrication protocols for these patients included making a set of models and a protrusive bite. The position for the protrusive bite was determined after approximately one hour on a TENS unit and the use of a Silascope from Myo-Tronics to identify maximum protrusion of the mandible. I felt that this might be too much, so I built the appliance 3mm short of maximum protrusion. I can’t be sure why I decided on this number.
WSN started sending some patients to me. Most of them had failed or refused C-PAP and had UPPP surgery done, which also failed in fixing the apnea, but did decrease the number of events. The appliance I made (by myself, in my office lab) was an acrylic one-piece that I cannot describe as comfortable. I am my own test subject prior to using on patients, and my wife told me I did not snore with it. The results of this study are published in Chest.1 We thought we had the answer but soon learned that for severe sleep apneics it was very limited.
I attended the first meeting of the medical sleep society in the spring of 1986 in Columbus, Ohio. At this meeting, I heard of an appliance called the Equalizer, made by Glaze Laboratory. This was a very bulky appliance and did not seem practical to me, however WSN wanted me to try one, since he was sure something better was out there than the one I had used so far. I tried an Equalizer and could not get it to fit the patient. When that meeting moved to Minneapolis in 1987, I was introduced to the Tongue Retaining Device. I also learned what the medical doctors thought of dentists doing anything in this field. I can’t remember all the names I was called, but I know I did not appreciate WSN calling me a “huckster.”

the first meeting of the medical sleep society was in the spring of 1986 in Columbus, Ohio

Late 1986 and 1987 was the introduction of the Snore Guard, which I created. I had to find injectable materials to fabricate the appliance in mass to keep costs reasonable, since insurance wasn’t going to pay for it. The outer shell of the appliance, Lexan, was easy to find. The moldable inside was not so easy. The mouth guard companies all claimed their materials as proprietary. Obtaining samples and then melting them involved ruining a few of my wife’s pots, but I ended up with Elvax, a DuPont product. At least these new appliances were being made in a manufacturing facility! Over the years I shared this information with several dentists who had different projects working toward the same objective.
This is about the time I started giving seminars around the country where most of the key founders of the Sleep Disorders Dental Society [now American Academy of Dental Sleep Medicine (AADSM)] first heard the idea of treating snoring with a dental device. Dr. Rob Rogers, who first convened the SDDS, told me at the AADSM annual meeting in 2012 that my three-hour course changed his life. My schedule was fun and relaxed – I would leave Albuquerque on Friday to speak somewhere that afternoon, somewhere else on Saturday and Sunday mornings, then home for four days in my practice. I would usually do this twice a month. My wife, mother-in-law, and I would paste labels, mail letters, and hope for a good response. On a nice snowy Friday in February, 1985, Dr. Alan Lowe invited me to Vancouver to speak to a group of dentists and hear about his research concerning the tongue.
By this time I had heard of Dr. Peter George (who claims to be the first with a device), Glenn Clark in Los Angeles, who was taking an orthodontic-centered approach, and Kent Toones, a Utah dentist who was producing an appliance that had a minimum of 20mm vertical opening. In my seminars, I would tell everybody that anything that would hold the mandible forward would help prevent snoring. In the late 1980’s, we did not have FDA clearance to talk about treating sleep apnea, but the future was becoming clear.
In 1990 or 1991, I met Christina LaJoie from Great Lakes Orthodontics Lab at a meeting in Los Angeles. She seemed to be a great friend of WSN but not interested in the Snore Guard. Because WSN supported and approved appliance therapy, she came around. Without WSN and her backing this new therapy, I feel the dental profession would have had to fight for several years longer to be accepted by the medical groups, which led directly to insurance companies paying for the therapy.
Winter_2015_Meade_appliances_In 1993, I developed the Thera-Snore and two years later the Adjustable Thera-Snore. These were both fitted with hot water – no laboratory required. And they received FDA clearance to treat sleep apnea along with snoring.
I sold my dental practice in 2002, keeping the right to treat patients with mandibular advancement appliances. Besides the Thera-Snore, I wanted to try out some of the other choices available, so I delivered several and was not satisfied when they seemed to last only two years. I thought my patients should expect more like five years of service. I wanted an appliance that would not stain and develop offensive odors. I jumped back into device development and spent two years of work with my dental lab technician producing what I wanted: a device that is nothing fancy but is basically indestructible. These goals along with a desire to minimize tongue space impingement led to the TheraSom Cast – a chrome-cobalt cast framework with about 7mm of advancement and a vertical of about the same. For patients with large tongues/restricted jaws, I usually open them about 10 millimeters, with generally good success.

In my 70’s I’m having a great time treating 8-9 patients a month.

I received the first appliance February 2009 and with a trip through the dishwasher once a week since then, it stays shiny. I have no idea how long it will last. I have found no reason to fabricate a morning deprogrammer appliance with this device, since I get great results with less protrusion. I am “retired” but still work a couple of four-hour days per week with no staff and nobody looking over my shoulder. With over half my professional career involved in this field, I still enjoy an ability to help people in a stress-free environment, independent of insurance or payment hassles. In my 70’s, I’m having a great time providing eight or nine new devices each month.
The only thing I am missing in these 30 years since working so hard to start appliance therapy for sleep breathing is any recognition from the AADSM.
This is a short essay of my journey, with a lot of interesting sidelines left out. Hope this helps you know a bit more about the history of dental involvement in this area of health care.

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