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Study Objectives: The objective of this study was to test a proprietary hard-acrylic computer-aided design/computer-aided manufacturing (CAD/CAM) oral appliance with “retainer-like fit” and determine whether it resulted in tooth movement upon regular wear over a minimum 2-year period. Additionally, this study focused on determining patient acceptance of said device considering any reported side effects. Methods: The 2-year clinical study reports on selected patients in whom sleep apnea has been diagnosed (n=18) recruited from The Snore Center in Calgary. Patients were fitted with a ProSomnus® Sleep Appliance. Impressions were taken at baseline, after approximately 1 year, and after 2 years of use with the oral appliance. Models were marked, scanned, and scored; upper and lower anterior teeth crowding was assessed; and overjet and overbite were measured independently at the University of Pacific. Patients were surveyed on compliance, satisfaction with the appliance, and quality of life using the Sleep Apnea Quality of Life Index (SAQLI-10). Results: This study shows a rigid OA made with proprietary CAD/CAM technology demonstrated no significant change in tooth position during the 2.3-year test period, or in bite changes per maximum intercuspation (MIP), as measured by overjet and overbite. At 2 years, the mean change in Little Irregularity Index for the lower anterior teeth was 0.007 mm (95% confidence interval = [-0.03, 0.05]), which was not statistically different from zero (P>0.05). Patients were highly satisfied with the device and considered it beneficial. Conclusions: A key component to any treatment is patient's acceptance of the appliance and the willingness to wear the OA long term. When patient compliance is observed, hard-acrylic sleep appliances have little effect on tooth movement and MIP bite changes as shown by overjet/overbite. Clinical Trial Registration: Health Research Ethics Board of Alberta: CTC-16-0108

Assessment of potential tooth movement and bite changes with a hard-acrylic sleep appliance: A 2-year clinical study.