Trial reportBMC oral health2025
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.
Trial report in BMC oral health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
8 authors.
Funding
Abstract
backgroundMandibular 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.
methodsA 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.
resultsBoth 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).
conclusionB-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 registrationThis 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.
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