Snoring is due to a partially collapsed airway. As tissues of the airway relax during sleep, the airway partially collapses, restricting airflow and causing vibration in the tissues, making the snoring sound. When the airway fully collapses, airflow is cut off and OSA occurs. Patients with untreated OSA may have an increased risk of developing cardiovascular disease, including difficult-to-control blood pressure, coronary artery disease, congestive heart failure, arrhythmias and stroke. Research also shows that OSA is associated with metabolic dysregulation, which affects glucose control and diabetes risk. It is important to note that there is a direct connection between snoring and sleep apnea: Although not every snorer has sleep apnea, every obstructive sleep apnea patient snores.

Mandibular advancement devices (MADs) have been clinically shown to be an excellent treatment for partial airway collapse. They look like an upper and lower mouthguard and work by engaging the teeth and holding the lower jaw forward, thereby maintaining an open airway. These mouthguards reduce upper airway collapse and eliminate vibration and the snoring sound. Many studies have shown that this protrusive jaw position is also a good way to reduce the number of OSA events per night, leading to a much deeper and restful night’s sleep.

Over-the-counter (available without prescription both in-store and online) snoring mouthguards are relatively inexpensive. The best examples of these devices form to the teeth by users placing them in boiling water for a few minutes, and then inserting them into the mouth and biting down for a semi-custom fit. This is a critical step to improved fit and function of the mouthguard. When it comes to sleep apnea, the FDA regulates all treatments for medical conditions. Sleep apnea is a medical condition, so a prescription is required to purchase treatment.

The key to using over-the-counter sleep devices is to assess the following questions: Do they work? Will they stop the snoring sound? Will they lower the apnea-hypopnea index (AHI), which is the key metric in measuring OSA severity? How do they compare to dentist-prescribed, fully custom laboratory-fabricated devices in the key areas of comfort, efficacy and compliance, which are very important for long-term use? Are these mouthguards clinically effective?

I have had many conversations over the years where it has been suggested that inexpensive, semi-custom, patient-made mouthguards may be a predictor of success. In fact, Kaiser Permanente^® hospitals use the ApneaRx^® mouthguard with a home sleep test to predict if the device is tolerated and effective before prescribing a fully custom, lab-fabricated oral appliance that is fitted by a dentist.

The ApneaRx is a semi-custom mouthguard. It is a micro-adjustable, thermoplastic (heat-molded) monobloc device that fixes the jaw in a set position. The patient forms the device in the same way as a traditional sports mouthguard. The thermoplastic material is placed in boiling water until it is soft enough to retain the impression of the teeth. The patient bites into the material and allows the material to cool and retain the shape of the dentition.

It is critical to the function of any oral appliance used in this way that the material forms around the curves and embrasures of the teeth with enough retention so that it does not come loose overnight. The mouthguard will only work when it is attached to the dentition and the jaw is held in a prescribed, clinically effective position.

In a 2014 TOMADO study, a crossover randomized controlled trial of oral mandibular advancement devices designed to treat obstructive sleep apnea-hypopnea, it was found that over-the-counter prefabricated thermoplastic devices were effective in reducing snoring and AHI. However, compared to custom-fabricated devices delivered in a dental office by a trained clinical team, they were less effective because they were poorly tolerated and fell out easily, so adherence was lower. This study also reviewed side effects that usually occur in the first few weeks of using a sleep device. These include hypersalivation, dry mouth, dental pain, gingival irritation, myofascial pain, tooth movement and temporomandibular joint (TMJ) discomfort. There were four serious adverse events during the trial (with those who either received or did not receive treatment), and transient events were experienced by 96% of study participants. The most common were discomfort and mouth problems (92%) and excess salivation (53%). The final outcome at the end of the study was that 81% of study participants continued with MAD therapy.

The advancement of the jaw for eight or more hours per night can lead to changes in the resting jaw position over time if left untreated. These side effects are not limited to over-the-counter sleep devices — they are also found in treatment with custom devices, according to the American Academy of Dental Sleep Medicine. A trained dental team is capable of addressing these side effects as a normal course of providing snoring and sleep apnea treatment. Some doctors advise patients to chew gum for five minutes first thing in the morning to relax and reset the jaw muscle. In the dental office, morning jaw exercises or an aligner, such as the AM Aligner, will be prescribed and delivered with a mandibular advancement device to manage changes like this.

In a 2007 study by Vanderveken et al., a group of ENT surgeons set out to compare the efficacy of boil-and-bite prefabricated appliances against the custom appliances made by a trained dentist. They found that in a randomized controlled crossover study, a custom mouthguard is more effective in the treatment of sleep-disordered breathing than an over-the-counter mouthguard. The numbers speak for themselves: Although the failure rate with the over-the-counter prefabricated thermoplastic device was 69%, the majority (63%) of these patients who experienced thermoplastic device failure were successfully treated with the custom-made device. At the end of the study, 82% of the patients preferred the custom-made device, and 9% had no preference.

A potential challenge when using a semi-custom, over-the-counter mouthguard is that patients can negatively select themselves out of qualification for mandibular oral appliance therapy by putting too much stock in their over-the-counter product experience. Boil-and-bite appliances made at home by the patient do not afford all the same features and benefits as a professionally made dental appliance fabricated and delivered by a trained team of professionals. Each of the studies reviewed for this article cited side effects that can be managed; however, each side effect on its own can be uncomfortable and disturbing to a good night’s sleep. Proper professional care is essential to achieve optimum clinical results.

To discover the simple, three-step process to screen and treat patients for snoring and sleep apnea, visit glidewelldental.com/pmad.

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