Original Title: Seguridad y eficacia de los dispositivos de avance mandibular en el manejo de la apnea obstructiva del sueño

Authors' objectives: Evaluate the efficacy, safety, indications, and costs of mandibular advancement devices (MADs) in the treatment of Obstructive Sleep Apnea (OSA) in adults. To achieve this, available evidence comparing MADs with continuous positive airway pressure (CPAP), placebo, or no treatment was synthesized, including comparisons between different types of MADs and before-and-after treatment analyses.

Authors' results and conclusions: In the exploratory search, 2 RS, 7 ECA, and 7 recommendation documents were identified. The results suggest that CPAP is superior to MADs in reducing AHI. However, MADs showed better patient adherence and acceptance; bimaxillary devices demonstrated greater efficacy compared to monoblock devices. Clinical recommendations suggest that MADs may be a valid alternative in patients with mild to moderate OSA, although the quality of evidence is very low. The updated search provided consolidated evidence supporting the superiority of CPAP in controlling respiratory parameters in moderate to severe OSA. Nevertheless, MADs offer significant clinical benefits in symptoms, functionality, and quality of life, especially when personalized and adjustable devices are used. Patients prefer MADs, as reflected in lower dropout rates and greater comfort. Evidence regarding side effects, impact on blood pressure, and daytime sleepiness was heterogeneous and dependent on the type of device and treatment duration. The evidence identified on the long-term impact of MADs, skeletal effects, treatment alternation, and individual adherence profiles was limited. From an economic perspective, although CPAP is generally more cost-effective in the long term, MADs represent an economically viable option, particularly for patients who cannot tolerate CPAP, and considering the healthcare system perspective. Current guidelines support the use of custom MADs in patients who meet established medical and dental criteria. Their use is recommended for patients with OSA of any severity who have difficulty adapting to CPAP, as well as for those with mild to moderate OSA who have no indication for CPAP or other therapeutic options, in cases of mild symptoms or bothersome snoring. The importance of continuous interdisciplinary follow-up is emphasized. Conclusions MADs constitute a valid therapeutic alternative for patients with OSA who cannot tolerate or use CPAP, especially when the devices are adjustable and personalized, as they show higher adherence and preference rates. In any case, further studies are needed on their long-term effects and on optimizing treatment personalization. Therefore, their use should be supervised by medical and dental teams.

Authors' methods: Two-phase literature review was conducted. First, an exploratory search of the PubMed and Embase databases was performed, including systematic reviews (SR), randomized controlled trials (ECA), economic studies, and recommendation documents published between 2017 and 2022. Subsequently, the search was updated to include more recent evidence from 2019 to 2025, with the aim of analyzing the evolution and consolidation of knowledge. The selection process included screening titles and abstracts, followed by prioritization based on methodological robustness, recency, and relevance for comparisons with MADs. Methodological quality was assessed using specific tools: AMSTAR II for SR, Osteba’s FLC for ECA and economic studies, and AGREE II for clinical recommendation documents.

Project Status: Completed

Year Published: 2026

URL for published report: https://www.euskadi.eus/contenidos/informacion/osteba_publicacion/eu_def/adjuntos/E-26-06-Dispositivos_de_Avance_Mandibular.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>