As obstructive sleep apnea becomes a more commonly diagnosed disorder, the demand for oral appliance therapy is on the rise, creating a niche market for laboratories. LMT takes a look at this blossoming field.
Five years ago, Alan Barnes, a dental laboratory consultant, couldn't make it through an entire movie without falling asleep, drive home without having to pull over and take a nap, or even attend a dinner party without drifting off at the host's house. In addition to his severe exhaustion, he was battling weight gain, high blood pressure, bad cholesterol and a sore throat due to excessive snoring.
After nearly 10 years of stumping doctors, Gene Rogers, Professional Dental Laboratory Corp., Elkhart, Indiana who hosts seminars on oral appliance therapy for treating sleep conditions——urged him to see a pulmonologist. He did, and after taking a simple sleep test, Barnes was diagnosed with obstructive sleep apnea* (OSA), a common disorder characterized by brief—but frequent—interruptions in breathing during sleep.
According to the American Sleep Apnea Association (ASAA), Barnes is one of the more than 12 million Americans who suffer from OSA, and it's estimated that 10 million more have yet to be diagnosed. However, diagnosing and treating OSA are on the rise thanks to a new generation of oral appliances (OAs) that are smaller, more economical and more comfortable; greater public awareness of the disorder; and changes in the marketplace.
One significant change occurred in 2006 when the American Academy of Sleep Medicine (AASM) changed its 2005 guidelines to say that sleep physicians could refer patients with mild to moderate OSA to dentists for oral appliance therapy in lieu of the previous standard methods of care, CPAP (Continuous Positive Airway Pressure) therapy or surgery. In terms of patient comfort and compliance, OAs are a vast improvement over CPAP masks that can be claustrophobic and uncomfortable because they cover the patient's nose and/or mouth.
In addition, as medical insurance companies have increased their coverage of OAs, physicians are prescribing an increasing number of OAs, and more and more patients are seeking treatment from their dentists. Consequently, laboratories that are fabricating these appliances are discovering a profitable niche market.
"The recent changes from the medical side have helped to secure a more favorable lab-dentist-patient outcome and helped this niche really take off," says Laura Sheppard, technical manager & training director, Davis Laboratory, Wyoming, Michigan. "The relationship between the dentist and medical community became stronger once OAs were recognized as a viable treatment option. As a result, patients now have a choice, more dentists are treating sleep apnea and custom OAs need to be fabricated by dental technicians. Everybody wins." Her laboratory has been involved with sleep medicine since 1989 and is one of the four Dental Services Group member laboratories—called the "Dream Team"—that manufacture oral appliances. In the past five years the Dream Team has experienced a 150% growth in this service and is currently fabricating about 300 Adjustable PM Positioners® and TAP® appliances per month.
Types of appliances
Although there are more than 30 different brands of oral appliances, all of them serve the same basic function: to keep the soft tissue from collapsing and interrupting normal breathing patterns. While the laboratory has to purchase brand-specific parts and materials through an oral appliance manufacturer or outside supplier, the fabrication process is similar to any orthodontic appliance: the lab receives models and a bite registration with a prescription from the dentist and then uses wire bending techniques, acrylic processing techniques and/or heat and pressure equipment to form the acrylic. The start-up cost, including equipment, materials and parts, is estimated to be about $5,000.
Typically, laboratories limit the number of OA brands they offer, opting to work with just a few companies and learn their appliances in depth. For example, Chad Rogers, technical director of Professional Dental Laboratory Corp., Elkhart, Indiana, only offers two brands of oral appliances—TAP® and OASYS™—because unlike some OAs, they treat both sleep apnea and snoring, making the appliances more marketable to his clients. He also likes the fact that both manufacturers offer good technical support and training DVDs. "Using the DVD, I learned how to fabricate TAP appliances in about one hour," says Rogers.
Some oral appliance manufacturers require you to get a license in order to fabricate and market their product, and the complexity of the licensing process and cost varies from brand to brand. For instance, to get licensed to offer TAP, you need to accurately fabricate one test appliance; the process takes about a week and there is no fee.
Because oral appliances are considered a Class II medical device, laboratories fabricating them are required to register with the FDA as a contract manufacturer and follow its documentation and labeling guidelines.
To ensure compliance with FDA requirements, DSG laboratories use a tracking system whereby a unique ID number is inserted into the upper and lower portions of the appliance. Using this number, the labs can easily confirm that the appliance was made by their laboratory and retrieve the digital case file that indicates the prescribing doctor, date, fabricating technicians, the QC supervisor and the materials/parts used in the appliance.
While oral appliance therapy is on the rise, there is still a need to educate dentist-clients about the treatment options. "I get a minimum of two calls per day from dentists who need help with an oral appliance case," says Sheppard. "We sponsor lectures and seminars and provide many dentists and staff Lunch & Learns on this subject. In this market, we've built a steel umbilical cord to the dentists because they need to be educated and are willing to learn."
Alan Barnes is being equally proactive. After his 2002 diagnosis and successful treatment, he formed the Barnes Group Sleep Division, a group consisting of 23 laboratories dedicated to educating dentists through seminars and informational materials on screening patients and offering OA treatment options. "This is a chance for lab owners to give total support to a dental practice for a growing field in dentistry," says Barnes. "If every dentist in the country got involved, 6% of their patients would have a better quality of living and increased lifespan. Not only is that a great reason to get involved, it's an important one," he says.
*What is obstructive sleep apnea?
Obstructive sleep apnea is a common sleep disorder characterized by brief interruptions of breathing that usually last 10-20 seconds or more, and occur five to 30 times per hour or more, during each sleep cycle. If left untreated, it can cause stroke, high blood pressure, cardiovascular problems and even death.