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Background <p>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.</p> Methods <p>A randomized controlled trial enrolled 24 OSAHS patients (AHI ≥ 5 events/hour), randomly assigned to B-MAD/CLB (<i>n</i> = 12) or M-MAD (<i>n</i> = 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.</p> Results <p>Both groups significantly improved in all outcomes post-treatment (<i>P</i> &lt; 0.05). At 2 months, no statistically significant differences were found in primary outcomes between groups (AHI: <i>P</i> = 0.34; LSaO₂: <i>P</i> = 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 (<i>P</i> &lt; 0.01).</p> Conclusion <p>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.</p> Trial registration <p>This study has been registered with the China Clinical Trial Registry (<a href="https://www.chictr.org.cn/">https://www.chictr.org.cn/</a>), with the registration number ChiCTR2500107457 and the registration date of August 12, 2025.</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月9日

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  • Jiangwei Liao,
  • Mingxin Zhang,
  • Dan Gan,
  • Yitong Liu,
  • Yi Dong,
  • Yingying Huang,
  • Yan Sun,
  • Junjie Wu

摘要

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.