0715 A Prospective, Multicenter, Real-world Study on the Long-Term Effectiveness of a CAD/CAM 3D-Printed Oral Appliance to Treat OSA: An Update

Abstract Introduction Oral appliance therapy (OAT) for treating obstructive sleep apnea (OSA) is one of the cornerstones of OSA management and requires multidisciplinary care management. When complete, the study will provide data on the use of the Panthera D-SAD, a CAD/CAM, 3D printed biocompatible nylon oral appliance. The primary endpoint of at least a ≥50% reduction in baseline apnea-hypopnea index (AHI) will be evaluated at five years, with interim sleep data at 3-6 months. The study fulfills French reimbursement requirements. Methods OAT naïve individuals with an AHI of 15-30 or those with severe OSA (AHI > 30) who decline CPAP and meet all other criteria will be included. Sites will follow the standard of care in France. Fifteen centers will enroll 217 participants via consecutive sampling. Participants will be medically and dentally evaluated. Evaluation time points are three to six months (sleep testing/medical), annual check-in, and five years (both). Secondary endpoints include side effects, oxygenation metrics, quality of life, self-reported adherence, and subjective symptoms. Ethics approval obtained. Results Enrollment is complete (N=257). Baseline demographics n=239 (mean/SD): Age 50.7 (12.8), BMI 26.6 (4.7), M 51%, AHI 22.7 (9.0), ODI 17.0 (11.4), lowest SpO2 84.6% (6.8), ESS >10, 42.4% (n=198). Change from baseline sleep respiratory variables at 3-6 Mos (n=179): a mean decrease in AHI of 10.5 (8.1) and an AHI reduction ≥ 50% in 60.3%. Additionally, 87.8% of moderate and 83.4% of severe transitioned to a lower AHI classification. ODI decreased to 9.7 (8.4). Subjective usage was sustained >4 hrs./night at six months in 94.8% of participants and 91.9% at one year (n=76), averaging 6.4 nights per week, demonstrating sustained adherence. Treatment satisfaction was 85.8% at three months. The mean ESS decreased from 9.1 (5.3) to 7.4 (4.8). The ≥50% AHI reduction was not influenced by BMI categories or gender, (p= 0.813 and 0.694, respectively). Conclusion These data demonstrate a reduction in total mean AHI with a substantial transition migration to a less severe AHI category. High OAT acceptance and adherence were found. In this sample, the percentage of patients whose AHI decreased by at least 50% does not differ between the subgroups. Support (if any) Panthera Dental Inc.