A pilot randomized trial of a novel digital mandibular advancement device with customized lip bumper: preliminary evaluation of treatment efficacy and relief of lower anterior dental pain in obstructive sleep apnea-hypopnea syndrome.

BACKGROUND: Mandibular advancement devices (MADs) are effective alternative therapies for obstructive sleep apnea-hypopnea syndrome (OSAHS). However, traditional monoblock mandibular advancement devices (M-MADs) often cause lower anterior dental pain and tooth displacement during long-term use, impairing compliance. Digital technology enables optimized appliance design. Therefore, we designed a novel digitally fabricated mandibular advancement device with a customized lip bumper (B-MAD/CLB) and compared its efficacy to the digitally fabricated M-MAD in treating OSAHS. METHODS: A randomized controlled trial enrolled 24 OSAHS patients (AHI ≥ 5 events/hour), randomly assigned to B-MAD/CLB (n = 12) or M-MAD (n = 12). Primary outcomes were apnea-hypopnea index (AHI) and lowest oxygen saturation (LSaO₂) measured via polysomnography (PSG) pre-treatment and at 1 and 2 months post-treatment. Secondary outcomes included Epworth Sleepiness Scale (ESS), Snoring Scale (SS), and a patient self-perception questionnaire assessing wearing comfort, retention, and lower anterior dental pain. RESULTS: Both groups significantly improved in all outcomes post-treatment (P < 0.05). At 2 months, no statistically significant differences were found in primary outcomes between groups (AHI: P = 0.34; LSaO₂: P = 0.44), though a trend toward greater AHI stability was observed for B-MAD/CLB (8.61 ± 7.51 vs. 11.95 ± 9.04 events/hour). Among secondary outcomes, B-MAD/CLB significantly reduced lower anterior dental pain (P < 0.01). CONCLUSION: B-MAD/CLB demonstrates superior efficacy to traditional M-MAD in alleviating dental discomfort, with no statistically significant difference in maintaining therapeutic stability compared to traditional M-MAD. TRIAL REGISTRATION: This study has been registered with the China Clinical Trial Registry ( https://www.chictr.org.cn/ ), with the registration number ChiCTR2500107457 and the registration date of August 12, 2025.