Effectiveness of a novel one visit 3D-printed titratable interlocking mandibular advancement device for patients with obstructive sleep apnea.

PURPOSE: To evaluate the effectiveness and treatment acceptance of a novel, self-titratable interlocking mandibular advancement device (KKU-MAD), fabricated using a fully digital, single-visit workflow, for managing obstructive sleep apnea (OSA). METHODS: This prospective clinical study enrolled adults diagnosed with mild to moderate OSA. Each received a customized KKU-MAD and underwent a 1- to 2-month acclimatization and titration period, starting with 50% mandibular protrusion and adjusted based on subjective improvements in snoring and daytime sleepiness, without unacceptable discomfort. Sleep parameters were assessed using a home sleep apnea test (HSAT). Patient-reported outcomes—including sleepiness, quality of life, treatment adherence, satisfaction, and side effects—were evaluated at baseline and post-treatment. RESULTS: Twenty-one participants (8 women, 13 men) completed the study. Significant improvements (p < 0.05) were observed in respiratory event index (REI: 14.7 ± 1.6 to 9.4 ± 1.3), supine REI (19.2 ± 1.9 to 11.0 ± 1.2), oxygen desaturation index (15.7 ± 1.9 to 9.8 ± 1.3), and percentage of snoring (23.7 ± 3.6 to 17.1 ± 3.8) (Mean ± SE). The Short Form-36 Health Survey showed significant improvement (p < 0.05) in role limitations due to physical and mental health domains. Participants used the device on average 7.3 h/night and 5.5 nights/week. Patient satisfaction was high (NRS 8.8 ± 1.3), with all participants continuing use of the device beyond the study period. Reported side effects were mild, transient, and did not lead to discontinuation. CONCLUSION: The KKU-MAD demonstrated significant improvements in sleep parameters, along with high patient adherence and satisfaction. Its fully digital, single-visit workflow reduces production time and offers practical and cost-effective alternative for OSA treatment. CLINICAL TRIAL REGISTRATION NUMBER: UMIN Clinical Trial Registry: UMIN000056614 Date of registration: 2/1/2025 Retrospectively registered