Evidence map›Paper›PMID 35532113›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2022

Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea.

Pien F N Bosschieter, Julia A M Uniken Venema, Patty E Vonk, Madeline J L Ravesloot, Aarnoud Hoekema, Joanneke M Plooij, Frank Lobbezoo, Nico de Vries

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 17% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Oral appliances for obstructive sleep apnoea in adults.The Cochrane database of systematic reviews · 2026
    Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Comparison of a noncustom vs custom mandibular advancement device to treat obstructive sleep apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 2 countries.

Pien F N BosschieterDepartment of Otorhinolaryngology, Head and Neck Surgery, OLVG, Amsterdam, The Netherlands.
Julia A M Uniken VenemaDepartment of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Patty E VonkDepartment of Otorhinolaryngology-Head and Neck surgery, Amsterdam UMC, Amsterdam, The Netherlands.
Madeline J L RaveslootDepartment of Otorhinolaryngology, Head and Neck Surgery, OLVG, Amsterdam, The Netherlands.
Aarnoud HoekemaDepartment of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Joanneke M PlooijDepartment of Oral and Maxillofacial Surgery, OLVG, Amsterdam, The Netherlands.
Frank LobbezooDepartment of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Nico de VriesDepartment of Otorhinolaryngology, Head and Neck Surgery, OLVG, Amsterdam, The Netherlands.
OLVG · NLAcademic Center for Dentistry Amsterdam · NLAmsterdam University Medical Centers · NLUniversity of Amsterdam · NLUniversity of Antwerp · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesNumerous types of mandibular advancement devices (MADs) are available to treat patients with obstructive sleep apnea, varying from noncustom to custom devices. Only a limited number of studies have been performed to determine whether a noncustom MAD could be used to predict treatment success of a custom MAD. In this study, we investigated the potential of a new-generation noncustom MAD, by comparing its effectiveness with a custom MAD. We hypothesized that the effectiveness of the devices is similar with regard to both objective (polysomnography) and self-reported (questionnaires, adherence, and patient satisfaction) outcomes.

methodsThis was a single-center prospective randomized crossover study including a consecutive series of patients with obstructive sleep apnea. Patients were randomized to start either with the noncustom or custom MAD. Both MADs were applied for 12 weeks, followed by polysomnography with MAD in situ and questionnaires. After the first 12 weeks of follow-up, a washout period of 1 week was applied. Equal effectiveness was defined as no significant differences in both objective and self-reported outcomes between both devices.

resultsFifty-eight patients were included; 40 completed the full follow-up. The median apnea-hypopnea index significantly decreased from 16.3 (7.7, 24.8) events/h to 10.7 (5.6, 16.6) events/h with the custom MAD (

conclusionsThe effectiveness of a noncustom and custom MAD is comparable, which suggests that a noncustom MAD can be used as a selection tool for MAD treatment eligibility to improve MAD treatment outcome. CLINICAL

trial registrationRegistry: Netherlands Trial Register; Name: The Use of a Boil and Bite Mandibular Advancement Device vs a Custom Mandibular Advancement Device in Obstructive Sleep Apnea Management; URL: https://www.trialregister.nl/trial/7249; Identifier: NL64738.100.18. CITATION: Bosschieter PFN, Uniken Venema JAM, Vonk PE, et al. Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea.

Indexed as

Mandibular AdvancementSleep Apnea, ObstructiveCross-Over StudiesHumansOcclusal SplintsProspective StudiesTreatment Outcomedrug-induced sleep endoscopymandibular advancement deviceobstructive sleep apneasleep-disordered breathingtreatment success

Identifiers

PMID35532113
PMCPMC9435323
OpenAlexW4229440342

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.