You Shouldn’t Have to Adjust

by Alexander T. Vaughan, DDS, MS, D.ABOP, and Michael S. Pagano, DDS, D.ABDSM

In 2019, the American Academy of Dental Sleep Medicine updated the published standards on the definition of an “effective oral appliance.” This paper has been foundational in setting standards for the industry, but we must remember its intent is the minimum standards, not the optimal form. Like most materials and appliances in dentistry, we have an abundance of options with their own advantages and disadvantages, but it’s up to the individual dentist to determine the “best fit” for them and their patients.

When starting our own dedicated DSM practice, we spent a significant amount of time debating which appliances we wanted to be our daily workhorses. Through this process we developed what we feel are criteria that will allow us to move beyond “effective” and into the realm of “practice defining” characteristics.

#1: First Time…Every Time

A mandibular advancement device (MAD) is a Class II medical device regulated by the FDA. As such, the approved instructions for use (IFU) must be followed for use to be considered “on label.” Unless the device IFU include directions for modification (as, for example, the TAP^® 3 ThermAcryl^® IFU does), any adjustments are “off-label” use.

Assuming we provide excellent records, we should expect a perfect fit and accept nothing less. As a profession, we have unfortunately accepted chairside adjustments as normal. We should ask ourselves, “would we routinely expect to adjust the intaglio of a crown or Invisalign aligners?” Why do we accept this with our MAD? How will these devices meet the needs of millions of people suffering from sleep apnea if the time involved cannot scale proportionally?

#2: Minimal Points of Adjustment

One of the great benefits of oral appliance therapy is ease of use and comfort compared to PAP. This mindset should extend to our appliance selection as well. We need to consider the patient experience during adjustment. When evaluating appliances, we found the overwhelming majority have 2 or more points of adjustment, such as bilateral jackscrews, maxillary and mandibular tray configurations, or bilateral bands, straps, or bars. Additionally, many devices require ordering additional pieces after the device has been delivered to the patient. This increases the number of follow-up visits required and the overall cost of therapy.

Our search only found two commonly prescribed appliances with a single advancement mechanism and all necessary parts of the device available at delivery without significant additional costs, namely the TAP^® line of appliances and the SomnoDent Avant™

#3: Manufacturing Partnership

Finally, we should consider partnering with a manufacturer that has a comprehensive appliance line. Not only does this allow for multiple appliances to select for the unique needs of each patient, but it also allows for improved dialogue between supplier and dentist.

We challenge all manufacturers to meet these standards: 1) First time fit with no chairside adjustments. 2) Single point advancement mechanism with all parts of the device necessary for its use available at delivery. 3) Excellent communication including necessarily delaying cases when in the patient’s best interest due to subpar records from the provider. Satisfying these criteria will result in better patient outcomes, more predictable chair time, and more closely align DSM expectations with those of our medical counterparts.