TY - JOUR
T1 - Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea
T2 - a randomized controlled trial
AU - Shi, Xiaoxin
AU - Lobbezoo, Frank
AU - Chen, Hui
AU - Rosenmöller, Boudewijn R.A.M.
AU - Berkhout, Erwin
AU - de Lange, Jan
AU - Aarab, Ghizlane
N1 - Funding Information: The authors gratefully acknowledge Dr. Naichuan Su, Department of Oral Public Health, Academic Centre for Dentistry Amsterdam (ACTA), for his assistance with the statistical analyses of this study; and the staff of the OLVG, Netherlands Slaap Instituut, Medisch Centrum Jan van Goyen and AMC for their assistance with this work. Funding Information: Xiaoxin Shi has received a scholarship from the China Scholarship Council. Publisher Copyright: © 2023, The Author(s).
PY - 2023/5
Y1 - 2023/5
N2 - Objectives: To compare the effects of two types of titratable mandibular advancement devices (MADs), namely MAD-H (allowing limited vertical opening) and MAD-S (allowing free vertical opening), on respiratory parameters and upper airway dimensions in patients with mild to moderate obstructive sleep apnea (OSA). Materials and methods: Patients with mild to moderate OSA (5 ≤ apnea–hypopnea index (AHI) < 30 /h) were randomly assigned to two parallel MAD groups. All MADs were subjectively titrated according to a standardized protocol during a 3-month follow-up. Every patient underwent two polysomnographic recordings, and two cone beam computed tomography scans in supine position: one at baseline and another one after 3 months with the MAD in situ. The primary outcome variables were the AHI in supine position (AHI-supine) and the minimal cross-sectional area of the upper airway in supine position (CSAmin-supine). Results: A total of 49 patients were recruited, and 31 patients (21 men and 10 women) with a mean (± SD) age of 48.5 (± 13.9) years and a mean AHI of 16.6 (± 6.7) /h completed the study. In the per-protocol analysis, there was no significant difference between MAD-H (n = 16) and MAD-S (n = 15) in their effects on AHI-supine (P = 0.14) and CSAmin-supine (P = 0.59). Similar results were found in the intention-to-treat analysis (P = 0.47 and 0.57, respectively). Conclusions: Within the limitations of this study, we conclude that there is no significant difference in the effects of an MAD allowing limited vertical opening and an MAD allowing free vertical opening on respiratory parameters and upper airway dimensions in patients with mild to moderate OSA. Clinical relevance: MADs allowing limited vertical opening and allowing free vertical opening have similar effects on respiratory parameters and upper airway dimensions in patients with mild to moderate OSA. Trial registration: ClinicalTrials.gov Identifier: NCT02724865. https://clinicaltrials.gov/ct2/show/NCT02724865
AB - Objectives: To compare the effects of two types of titratable mandibular advancement devices (MADs), namely MAD-H (allowing limited vertical opening) and MAD-S (allowing free vertical opening), on respiratory parameters and upper airway dimensions in patients with mild to moderate obstructive sleep apnea (OSA). Materials and methods: Patients with mild to moderate OSA (5 ≤ apnea–hypopnea index (AHI) < 30 /h) were randomly assigned to two parallel MAD groups. All MADs were subjectively titrated according to a standardized protocol during a 3-month follow-up. Every patient underwent two polysomnographic recordings, and two cone beam computed tomography scans in supine position: one at baseline and another one after 3 months with the MAD in situ. The primary outcome variables were the AHI in supine position (AHI-supine) and the minimal cross-sectional area of the upper airway in supine position (CSAmin-supine). Results: A total of 49 patients were recruited, and 31 patients (21 men and 10 women) with a mean (± SD) age of 48.5 (± 13.9) years and a mean AHI of 16.6 (± 6.7) /h completed the study. In the per-protocol analysis, there was no significant difference between MAD-H (n = 16) and MAD-S (n = 15) in their effects on AHI-supine (P = 0.14) and CSAmin-supine (P = 0.59). Similar results were found in the intention-to-treat analysis (P = 0.47 and 0.57, respectively). Conclusions: Within the limitations of this study, we conclude that there is no significant difference in the effects of an MAD allowing limited vertical opening and an MAD allowing free vertical opening on respiratory parameters and upper airway dimensions in patients with mild to moderate OSA. Clinical relevance: MADs allowing limited vertical opening and allowing free vertical opening have similar effects on respiratory parameters and upper airway dimensions in patients with mild to moderate OSA. Trial registration: ClinicalTrials.gov Identifier: NCT02724865. https://clinicaltrials.gov/ct2/show/NCT02724865
KW - Cone beam computed tomography
KW - Freedom of mandibular vertical opening
KW - Mandibular advancement device
KW - Obstructive sleep apnea
KW - Upper airway dimensions
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U2 - https://doi.org/10.1007/s00784-023-04945-z
DO - https://doi.org/10.1007/s00784-023-04945-z
M3 - Article
C2 - 36928350
SN - 1432-6981
VL - 27
SP - 2013
EP - 2025
JO - Clinical Oral Investigations
JF - Clinical Oral Investigations
IS - 5
ER -