by Mark T. Murphy, DDS, FAGD
Although not technically part of the Hippocratic Oath1, “first do no harm”, is a standard component of good medical and dental care. Side effects are a necessary evil that are secondary to the intended effect; the term is predominantly employed to describe adverse outcomes. Numerous studies show that physicians and patients care about Oral Appliance side effects and that they may impact referral decisions. The American Academy of Dental Sleep Medicine published a position paper, “Management of Side Effects of Oral Appliance Therapy for Sleep-Disordered Breathing”2, to provide guidelines. Prosomnus® Sleep Technologies is making an effort through product development and scientific studies to enable dentists to mitigate these risks while still achieving successful treatment outcomes.
Good medicine would prescribe avoiding, minimizing or at least managing unwanted side effects without compromising the quality of primary care. Common examples of mild adverse effects related to drugs include: constipation, skin rash, diarrhea, dizziness, drowsiness, dry mouth or headache. The therapeutic benefit may far outweigh these inconveniences. If we could prevent or avoid side effects while still achieving the desired result, that would be preferable.
For CPAP therapy, patients may experience nasal problems (e.g., rhinorrhea, epistaxis, URI); mask problems (e.g., dermal abrasion due to poor fit, conjunctivitis due to air leaks); flow problems (e.g., difficulty exhaling); and other types of difficulties that interfere with effective therapy3. Claustrophobia, headaches, belly bloating, difficulty with nocturnal bathroom visits and machine noise are also mentioned as challenges. However, despite advancements in size, portability, titration, noise, and mask fit, studies report that CPAP compliance rates remain well below the recommended threshold of > 4 hours on at least 70% of nights4.
Historically, OAT patients have had a list of unwanted side effects to therapy. Not only can these sequelae interfere with compliance and treatment, physicians often sight them as reasons to prescribe CPAP. Today, not only are we aware of CPAP’s own side effects, but the next generation of oral appliances from ProSomnus are designed to prevent and minimize untoward outcomes from OAT. The AADSM and AASM list of OAT side effects includes: joint discomfort, noise, tender muscles, soft tissue irritation, excessive salivation, dry mouth, occlusal changes, tooth movement, metal allergies, hygiene issues, gagging, and restoration and appliance breakage. On the next page is a list of next generation oral appliance improvements from ProSomnus that were not available just a few years ago.
Two of the causes of joint pain and discomfort in OAT are excessive/rapid advancement and asymmetrical titration. The engineered, precision design ensures that the mandible is advanced in a true A/P direction regardless of the arch shape or angulation. Several clinicians report less advancement because of the lower material volume and greater tongue space.
A recent study and poster presented at the AADSM Annual Meeting (with models and measurements made independently in the Orthodontic department at the University of the Pacific) demonstrated no significant tooth movement over a 2.3-year period using the Littles Index. Addtionally, no statistically significant change was reported in overjet or overbite when the models were placed in MIP (Maximum Intercuspation)5. It is noteworthy that the ProSomnus Sleep Device was used without ball clasps or a soft liner and confirms the goal of a retainer-like fit.
Soft Tissue Irritation
Smoother, more comfortable oral appliances with less obtrusive advancement mechanisms provide less cause for soft tissue irritation. The ProSomnus [IA], an Iterative Advancement Device, has no screws, mechanisms, or elastics required other than the contoured posts. The ProSomnus [CA], a Continuous Advancement Device, has been designed with patient comfort in mind.
ProSomnus uses digital technology to design and manufacture a precision Morning Occlusal Guide or [MOG]. Not only does it help reposition the condyles in the morning, but the precise tooth position is stored so that if the need should arise, a new MOG could be milled easily from those records.
The ProSomnus [IA] has no metal components. The dense milled control-cured medical grade PMMA leaches less monomer than any of the handmade predicate devices.
Less overall volume, patient centric designs and standard Dual 90º Posts allow ProSomnus Devices to create less lip competency problems and ergo, dry mouth. Milled elastic hooks are a feature that can be a requested if desired.
A UoP study demonstrated no significant tooth movement over a 2.3-year period.
The stronger control-cured medical grade PMMA performs better than predicate devices in strength and breakage testing.
All ProSomnus Devices are milled from a dense control-cured medical grade PMMA puck. Besides being stronger and smaller, the material density provides less of a substrate for bacterial growth and stain.
The precision fit of the ProSomnus Sleep Devices is unlike other retention solutions presented to date. Ball clasps mean the fit of the device is not good enough for retention and ergo, the metal balls provide that. Biting on or into acrylic versus a metal ball clasp is potentially far less damaging to restorative materials.
Smaller devices allowing more tongue space will always be less of an irritant than larger, bulkier solutions.
So, what does this really mean? With fewer side effects and better therapeutic outcomes, there is a better choice to treat OSA. Patients should understand, be presented all options, and be involved in making health care decisions about treatments, their side effects and the risks and rewards of each. The design and engineering of ProSomnus Sleep Devices provide a next generation solution that is intended to be better for patients and engage more physicians. ProSomnus is far from done. Continuous Advancement is more than the name of our newly launched Sleep Device. It is a way of approaching and solving the Sleep Apnea crisis in the world today. With an estimated 1 billion sufferers worldwide6, we need better coordinated patient centric solutions that are examples of precision medicine. ProSomnus’ charge is treating more patients with greater efficiency, efficacy and effectiveness while reducing side effects to provide better outcomes.
- Hippocratic Oath, NIH National Library of Medicine Medical History Section. https://www.nlm.nih.gov/hmd/greek/greek_oath.html/.
- Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy: an update for 2015. Journal of Dental Sleep Medicine 2015;2(3):71– 125.
- Side Effects of CPAP Therapy, NIH, National Heart, Blood and Lung Institute; https://www.nhlbi.nih.gov/node/4248/.
- Rotenberg et al. Trends in CPAP adherence over twenty years of data collection; A flattened curve, Journal of Otolaryngology – Head and Neck Surgery (2016) 45:43 DOI 10.1186/s40463-016-0156-0.
- Vranjes et al, Tooth Movement and Bite Changes for a Hard-Acrylic Sleep Appliance; 2 Year Results; Poster Session at the AADSM Annual Meeting, Baltimore, MD 2018.
- Benjafield et al. Global Prevalence of OSA in Adults; Estimation Using Currently Available Data. Thematic Poster Session American Thoracic Society Annual Meeting, San Diego, CA 2018.