Evidence map›Paper›PMID 36928350›Full record

Trial reportClinical oral investigations2023

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: a randomized controlled trial.

Xiaoxin Shi, Frank Lobbezoo, Hui Chen, Boudewijn R A M Rosenmöller, Erwin Berkhout, Jan de Lange, Ghizlane Aarab

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical oral investigations, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02724865 phase4unknown statusnot on this map

A Comparison Between Two Different Oral Appliance Therapies: Somnodent vs Herbst Appliance in Patients With Mild and Moderate OSA

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2016 to 2018Enrolled140ConditionsObstructive Sleep ApneaArmsSomnodent® (Oral appliance therapy), Herbst® (Oral appliance therapy)
NCT06810479 nacompletednot on this mapstarted 2025, after this paper: background citation

A Randomised, Controlled Cross Over Study Comparing Two Mandibular Advancement Devices in the Treatment of Mild-to-moderate Obstructive Sleep Apnea

TypeinterventionalSponsorZiekenhuis Oost-LimburgRan2025 to 2026Enrolled16ConditionsApnea, ObstructiveArmsPolygraphy, Questionaire, Question
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Comparison of side effects of different mandibular advancement devices for patients with obstructive sleep apnea: a systematic review and meta-analysis.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Xiaoxin ShiDepartment of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, 1081 LA, the Netherlands.
Frank LobbezooDepartment of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, 1081 LA, the Netherlands.
Hui ChenDepartment of Orthodontics, School and Hospital of Stomatology, Cheeloo College of Medicine, Shandong University & Shandong Key Laboratory of Oral Tissue Regeneration & Shandong Engineering Laboratory for Dental Materials and Oral Tissue Regeneration, No. 44-1 Wenhua Road West, Jinan, 250012, Shandong, China. h.chen@sdu.edu.cn.
Boudewijn R A M RosenmöllerDepartment of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, 1081 LA, the Netherlands.
Erwin BerkhoutDepartment of Oral Radiology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, 1081 LA, the Netherlands.
Jan de LangeDepartment of Oral and Maxillofacial Surgery, Academic Centre for Dentistry Amsterdam (ACTA) and Amsterdam University Medical Centers, Amsterdam, the Netherlands.
Ghizlane AarabDepartment of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, 1081 LA, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo 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

methodsPatients 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).

resultsA 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).

conclusionsWithin 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 registrationClinicalTrials.gov Identifier: NCT02724865. https://clinicaltrials.gov/ct2/show/NCT02724865.

Indexed as

Mandibular AdvancementSleep Apnea, ObstructiveAdultCone-Beam Computed TomographyFemaleHumansMaleMiddle AgedOcclusal SplintsTreatment OutcomeCone beam computed tomographyFreedom of mandibular vertical openingMandibular advancement deviceObstructive sleep apneaUpper airway dimensions

Identifiers

PMID36928350
PMCPMC10160211

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.