The development of a novel bidirectional fine-tuning mandibular advancement device.

ABSTRACT

OBJECTIVE: To develop a novel mandibular advancement device (MAD) with high comfort, good compliance, and bidirectional fine-tuning capability for patients with obstructive sleep apnea hypopnea syndrome (OSAHS), and to evaluate the therapeutic efficacy of the new MAD. METHODS: The MAD, featuring upper and lower dental splints with a fine-tuning mechanism for mandibular adjustment, incorporates improved design elements such as partial dental coverage, shortened baffles, and memory resin lining. The novel MAD was used to treat 30 OSAHS patients in the study, comparing pre- and post-treatment scores on the Epworth Sleepiness Scale (ESS), the Apnea-Hypopnea Index (AHI), and the lowest oxygen saturation (LSO2). RESULTS: The novel MAD reduced size and side effects, enhancing comfort. All patients complied well, using it for an average of 95% over 30 days and ≥ 5 h nightly. After treatment, significant improvements were observed in ESS, AHI, and LSO2 (P < 0.05). CONCLUSIONS: This novel bidirectional adjustable MAD provides high comfort and compliance, improving treatment precision. It is an effective choice for mild to moderate OSAHS patients and an alternative for those intolerant to CPAP or averse to surgery.