Oral appliances for sleep apnea offer new opportunity for laboratories
By Daniel Alter, MSc, MDT, CDT
Some people may be waking up to the sobering fact that they may not be receiving the regenerative sleep required to live a healthy life. According to the National Sleep Foundation, a common but potentially life-threatening sleep issue called obstructive sleep apnea (OSA) may be robbing more than 18 million adult Americans of restful sleep, and millions more with symptoms are not yet diagnosed. The condition can affect all age groups; however, it’s unclear how many children and teenagers have the condition.
Society is attempting to address the issue as it comes to the forefront. Airlines, transportation companies, and many other businesses are instituting new policies that require employees to undergo medical evaluations to determine their at-risk status for a sleep disorder. If found positive, employees in many cases must comply with treatment protocols to maintain their jobs. The recognition of sleep apnea as a serious health issue and new initiatives to identify at-risk populations are positioning dentistry as a solution provider. Clinicians and laboratories are poised to provide a wealth of patient education, diagnosis, and successful treatment protocols and appliances to alleviate the effects of OSA.
OSA is a sleep-related disorder manifested by the collapse of the pharyngeal airway. This subsequently leads to repeated episodes of airflow cessation (decrease or complete halt in airflow), oxygen desaturation, and multiple sleep disruptions.1 The muscles near the pharynx and the back of the throat relax during sleep, causing soft tissue to collapse and block the airway2 (Figure 1). When the airway is blocked, the pause in breathing usually lasts 10 to 30 seconds; some patients, however, may exhibit breathing cessation for as much as 1 minute or longer. The result and symptom manifestation of this sleep disorder is an abrupt reduction in blood-oxygen saturation, with some cases showing a drastic reduction of as much as 40% or more. These episodes provoke the brain to respond to the lack of oxygen by alerting the body (stimulating the epinephrine hormone, also known as the fight or flight hormone), and causing a brief arousal from sleep to resume regular breathing. In patients with OSA, this scenario can occur hundreds of times a night, fragmenting the needed regenerative sleep and producing an excessive feeling of daytime fatigue or sleepiness.2 However, these awakenings are typically not complete, so the sleeper might be unaware of the breathing issues during the night. These patients also produce excessively loud snoring. Furthermore, patients with OSA are at increased risk for chronic elevation in daytime blood pressure, which, in turn, leads to increased risk for stroke, a higher risk for death due to heart disease, impaired glucose tolerance, impaired concentration, mood changes, and increased risk for being involved in a deadly motor vehicle accident.3
Three known treatment protocols can treat OSA. Traditionally, the continuous positive airway pressure (CPAP) has been prescribed for moderate-to-severe cases of OSA. CPAP provides a steady stream of pressurized air to patients through a mask that the patient must wear while sleeping. However, this treatment modality often leads to ineffective results, due largely in part to noncompliance of the patient because of the mask’s bulkiness and discomfort.2
A second option is the oral appliance, or the mandible forward displacement appliance (Figure 2). This appliance widens, repositions, or stabilizes the mandible retro-palatal airway patency, as well as the base of the tongue, soft palate, or uvula in the passive pharynx, and therefore hinders the collapsibility of the pharynx during sleep4 (Figure 3). Mandibular advancement oral appliances are typically the first solution for the approximately 90% of patients diagnosed with mild and moderate OSA symptoms. These oral appliances can be significantly more effective because many patients find this treatment more comfortable, lessening patients’ hesitation in wearing them at night.
When noninvasive treatment modalities are unsuccessful, surgical options can correct or alleviate the problem.2
OSA and Dentistry
The dental profession is in an excellent position to recognize and tackle this epidemic because 90% of the obstruction occurs behind the maxilla and mandible and in the region of the soft palate, tongue, and lateral fat pads.3 The airway is critically significant in dentistry and medicine, because the airway, proper oxygenation, and breathing are the most important and necessary functions for humans. Statistics show about 80% to 90% of adults with OSA have not received a diagnosis.2 Dentists can play an important role in testing and commencing the conversation with their patients, who concurrently may have other existing and contributory dental ailments, including the under-recognized, devastating effects of the removal of the bicuspids during orthodontic treatment, which may require restorative options to remediate symptoms.
If a patient is suspected of having OSA, the first step for the dentist is to recommend a home sleep test such as Ez Sleep SystemTM (Ez Sleep, ezsleeptest.com). This system incorporates an assessment tool designed for healthcare professionals to deploy in the office. Then, the provider can give the patient an at-home, self-administered test, which is comprised of a sensor that the patient affixes with straps onto the forehead before bedtime for one or two nights. The sensor records oxygen levels, snoring, and deep sleep disruptions. Then, the patient mails the device to the company for the results to be read and sent to the ordering dentist. The comprehensive sleep report (Figure 4) is read by a board-certified sleep specialist, the only health care providers permitted to diagnose sleep disorders. From there, the diagnosis and treatment recommendations are sent to the patient’s dentist. If desired, a dentist can consult with an ear, nose, and throat specialist and the dental laboratory for appliance fabrication. A knowledgeable team approach, utilizing clinical and laboratory experts, is optimal in finding treatment solutions for success. Self-guided home sleep studies appear as effective as in-hospital studies for diagnosis of OSA without comorbidities.9
The aforementioned mandibular advancement device, or oral appliance (OA), is an approved and frequently effective treatment protocol. In 2006, the American Academy of Sleep Medicine published updated OSA treatment guidelines stating that oral appliances are a reasonable alternative to CPAP. Mandibular advancement devices provide a therapeutic effect by protruding the mandible relative to the maxilla, simultaneously advancing the tongue and reducing the propensity for airway collapse during sleep5,6 (Figure 5). Although these types of oral appliances have multiple variations, they fall into two main categories: fixed or adjustable. Both variations are fabricated from models of the patient’s dentition to fit the mandibular and maxillary teeth.5 The primary difference between the two types is the amount of titration, or slow addition of mandibular advancement, that can be achieved. Fixed oral appliances are usually made to advance the mandible 50% to 80% and are fabricated in a permanent position. Adjustable oral appliances can be further titrated to optimize the therapeutic efficacy (Figure 6). If the appliance is adjustable, either the patient or clinician may incrementally adjust or advance it in order to achieve an optimal position for improving sleep continuity, reducing snoring, and alleviating obstructive events.5,7 Adjustable oral appliances enable adjustments without the need to recreate or reset the appliance. In a study of adults with sleep-disordered breathing, Kato et al8 found oral appliances successfully mitigated pharyngeal collapsibility.
OSA and the Dental Laboratory
Advancements in digital technologies have resulted in rapid developments in materials and techniques for fabricating oral appliances. Oral appliances are made of biocompatible materials that must engage both the maxillary and mandibular arches with great precision. This level of detail affords the patient the enhanced experience of comfort. The newer generation of oral appliances are produced from 3D-printed thermoplastic materials for both the maxillary and mandibular arches, along with their titration rods (Figure 7). Multiple titration rods allow the patient to make adjustments in 1-mm increments with a protrusive adjustment range of at least 5 mm.6 The patient simply replaces the titration rods to advance the mandible until obstructive sleep apnea symptoms lessen or subside.
Another recent innovation in OSA oral appliance compliance comes from Panthera Dental (pantheradental.com). The company recently launched D-SAD, or the digital sleep apnea oral device, with an integrated compliance sensor. This digital recorder has a lifetime battery and is inserted into the oral appliance with a chip providing downloadable data. Patients mandated by employers to use such a device can provide their companies, unions, associations, and insurance providers with clear and usable data regarding compliance and legal proof if such a situation should arise. Furthermore, the same digital recorder can be read at the clinician’s office to assess if the patient was compliant with the treatment protocol and goals, making needed treatment decisions more relevant and leading to an enhanced level of treatment success.
Dental laboratories can benefit greatly by gaining knowledge about this market and providing their customer bases with another dental solution, which ultimately produces a new source of business revenue. Hosting a study group or seminar on sleep medicine for existing clientele and new or prospective customers provides a relevant source of education that will differentiate your business from the competition. The dental laboratory can furthermore be the vehicle by which the dentist can provide these oral appliance solutions to their patients. Once the dentist impresses both arches, the dental laboratory can pour the impressions in gypsum material, and void any bubbles or tears that may negatively affect the fit of the mandibular advancement oral appliance. In the new age of digital dentistry, some companies also have the ability to forego the costly and time-consuming model production and fabricate these devices directly from approved intraoral scan technologies.
The problem of OSA is in epic proportions and needs to be addressed with proper care. Treatment initiatives will not only provide better overall health and well-being for afflicted individuals but could potentially save them from a catastrophic consequence, alleviate existing medical conditions, and improve quality of life. It also provides another obvious scope of treatment for the dental professional; the dentist can treat a large segment of the practice’s existing patient base and attract new patients seeking help with OSA. Furthermore, the dental laboratory can become the conduit by which the oral appliance is manufactured, making this a true win-win-win for all involved.
The author thanks Michael Gelb, DDS, MS, Owner of the Gelb Center in New York, for the images.
About the Author
Daniel Alter, MSc, MDT, CDT, is a consultant and Professor at New York City College of Technology.
The author had no disclosures to report.
1. Schellenberg JB, Maislin G, Schwab RJ, et al. Physical findings and the risk for obstructive sleep apnea. The importance of oropharyngeal structures. Am J Respir Crit Care Med. 2000;162(2 Pt 1):740-748.
2. Obstructive sleep apnea. American Academy of Sleep Medicine. 2008. http://www.aasmnet.org/resources/factsheets/sleepapnea.pdf. Accessed November 5, 2015.
3. Gelb ML. Airway centric TMJ philosophy. J Calif Dent Assoc. 2014;42(8):551-562.
4. Fleury B, Rakotonanahary D, Petelle B, et al. Mandibular advancement titration for obstructive sleep apnea: optimization of the procedure by combining clinical and oximetric parameters. Chest. 2004;125(5):1761-1767.
5. Lettieri CJ, Paolino N, Eliasson AH, et al. Comparison of adjustable and fixed oral appliances for the treatment of obstructive sleep apnea. J Clin Sleep Med. 2011;7(5):439-445.
6. Definition of an Effective Oral Appliance. Journal of Dental Sleep Medicine. March 22, 2013
7. Trudo FJ, Gefter WB, Welch KC, et al. State-related changes in upper airway caliber and surrounding soft tissue structures in normal subjects. Am J Respir Crit Care Med. 1998:158(4):1259-1270.
8. Kato J, Isono S, Tanaka A, et al. Dose-dependent effects of mandibular advancement on pharyngeal mechanics and nocturnal oxygenation in patients with sleep-disordered breathing. Chest. 2000;117(4):1065-1072.
9. Domingo C, Vigil L. Effectiveness of unattended ambulatory sleep studies for the diagnosis and treatment of OSAS. J Eval Clin Pract. 2011;17(1):26-31.
How Laboratories Can Tap Into the Sleep Market
By Jason Mazda
The US market for oral appliances to treat Obstructive Sleep Apnea is projected to more than double from 2013 to 2020, increasing from approximately $250 million to nearly $600 million, according to a 2014 Frost & Sullivan report.1 Custom appliances, which occupied only about a quarter of the market in 2013, are expected to account for more than half in 2020 — nearly $350 million.
For dental laboratories, this means that if your dentist-clients are not requesting sleep appliances already, they soon may.
"Five years ago, the market was small and slow in this area, but it is starting to gain serious traction," says Brad Chott, Specialty Appliance Manager for Keller Laboratories in St. Louis, Missouri.
Like with any other service, laboratories have two choices when getting started: Fabricate the product in-house, or utilize an outsource partner.
Keller, a full-service laboratory, entered the sleep market approximately seven years ago, fabricating appliances such as TAP (Airway Management, tapintosleep.com) and EMA (Myerson, myersontooth.com) in-house. Devices such as those receive FDA 510(k) clearance through the developers, who provide kits and/or licenses to produce them. However, the FDA still requires the laboratory to register and "list the devices and the activities performed on those devices at that establishment,"2 keeping records available upon request. Registration costs $3,845 for 2016.
The profit margin for sleep devices is comparable to other products in a full-service laboratory, Chott says — perhaps slightly more than the margin for a single-unit crown. While sleep appliances are priced higher, the material costs offset that revenue somewhat. The labor, Chott says, is 3-4 times what is required for producing a night guard.
"We produce approximately 20 sleep devices per day, so it has been a positive addition to our business," Chott says.
For laboratories that prefer to gauge demand and gain experience with a minimal investment, outsourcing is an option. Laboratories can outsource the device manufacturing to FDA-registered laboratories that specialize in sleep devices or to production facilities such as Panthera Dental (pantheradental.com). Laboratories outsourcing the production of sleep devices within the US are not required to register with the FDA if they do not repackage or relabel the device, a representative from the FDA's Center for Devices and Radiological Health confirmed (see Table 1 for a list of who must register).
Philip "Sonnie" Bocala, CEO and Founding Partner of T&S Laboratory in La Mesa, California, which specializes in sleep appliances, says he is working on several partnerships with laboratories seeking to enter the sleep market. The collaborative effort between distributing partner laboratories and manufacturing laboratories essentially could allow for continued direct customer care between laboratories and their clients in addition to offering a wide range of sleep appliances.
"Many laboratories do not want to interrupt their workflow or invest in more equipment and training," Bocala says, "but they want to offer their existing clients this option in order to serve them better."
The role of the partner laboratory should not be understated, according to Jim Addiego, Manager of Dream Systems Dental Sleep Laboratory in Roseville, California. While Addiego’s laboratory is involved in design and fabrication of appliances, the partner laboratories are responsible for understanding the indications, benefits, and limitations of the devices, as well as assisting dentists in fulfilling the requirements for impressions and construction bites, and providing assistance with delivery, adjustment, and troubleshooting questions.
"If we cannot work with what we are provided, the whole process will be delayed," Addiego says.
Indeed, Chott says, bite information from the dentist is of the utmost importance for sleep devices, especially dorsal types.
"We are titrating a person’s jaw with these devices," Chott says. "If the dentist sends an inaccurate bite, or the patient can move his/her jaw farther forward than the dentist thought, then you need to make adjustments. It can be a challenge."
The appliances vary in degree of difficulty to produce. Though some appliances are relatively simple to fabricate, others require a high level of skill and experience. While Dream Systems fabricates its devices by hand, some laboratories, including Bocala’s T&S, incorporate digital aspects such as 3D printing.
The most crucial step a laboratory must take, these experts agree, is to become extensively educated on sleep medicine overall.
"It is important to understand that these are medical devices that we are making in the dental laboratory," Addiego says.
Bocala says adequately educating oneself on this subject is not easy, because most of the courses being offered promote a specific product. However, he says it is paramount to learn about a wide range of options and about sleep medicine in general.
"Dentists often see value in laboratories that are able to assist them in finding the correct solution to reflect their diagnosis and treatment plan," Bocala says. "The laboratories that succeed in this market will be the ones that are educated about a wide array of options, so they can help dentists offer the best options to patients."
The potential exists for the sleep market to be worth the effort involved for laboratories. Bocala has specialized in sleep appliances for almost 10 years, and he says based on recent trends and demand he expects his 15-person laboratory to expand to "upward of 20-25" by the end of 2016. Addiego’s operation, meanwhile, has expanded from two people to 10 in less than five years. Chott says in addition to Keller’s success with sleep devices, he has witnessed more dentists each year attending American Academy of Dental Sleep Medicine meetings.
"There is a great demand for oral appliance therapy for treatment of sleep disordered breathing," Addiego says. "It is a field of dentistry that is growing and will continue to grow. We, as laboratories, need to continue to grow in our knowledge, to better serve and support our dentists and to help make a difference in patients' lives."
1. Shelton T. The Price of a Good Night’s Sleep: Insights into the US Oral Appliance Market. Vital Signs. http://www.marketresearch.com/product/sample-8745989.pdf. Accessed November 18, 2015.
2. Who Must Register, List and Pay the Fee. U.S. Food and Drug Administration web site. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm. Updated August 15, 2014. Accessed November 23, 2015.