0367 Novel 3D-Printed Custom Oral Appliance Therapy: A Pilot Study

Abstract

Introduction Oral appliance (OA) therapy protrudes the jaw in a more anterior position during sleep to treat obstructive sleep apnea. OA therapy can be used in combination or as an alternative to positive airway pressure (PAP) therapy. Most custom oral devices are fabricated with expensive manufacturing equipment or individually hand-made increasing treatment costs that prevent access to care for patients. Previous studies report concerns of cost-effectiveness of OA therapy and surveys of sleep physicians with cost concerns leading to barriers in prescribing OA therapy. More recent technological advancements in additive technology have allowed low-cost, custom fabrication of digitally designed OA. To date there have been no clinical studies that the authors are aware of that have investigated the feasibility of offering 3D printed custom OA therapy. Methods A novel OA was designed specifically for 3D-printing with additional features to improve clinician efficiency, patient comfort, and patient safety. A review of 3D-printed materials was completed to ensure biocompatibility requirements prior to clinical testing. Approval from the Committee for Protection of Human Subjects of University of Texas Health Science Center at Houston was obtained. Five participants had novel OA digitally designed based on scans of upper and lower teeth in addition to a bite registration recorded using a George Gauge. Participants were surveyed based on comfort of device and safety monitoring. Results Participants found the novel OA generally comfortable. Comfort questions were presented on a scale of 1 – 10, where ten is the highest level of comfort. On average participants found that the novel OA had comfort levels of 9.0 ± 0.77 on gums, 8.2 ± 0.92 on teeth, and 9.8 ± 0.20 of the jaw joints. No major adverse events were reported and the most common minor adverse event reported was increased salivation. Conclusion This pilot study illustrates the clinical feasibility of a novel 3D printed OA. Future studies will further investigate patient outcomes and clinician efficiency during clinical implementation of this novel OA. Though the use of 3D-printing technologies OA therapy has the potential to be offered at lower cost and delivered to the patient in one visit representing a paradigm shift. Support (If Any)