Evidence map›Paper›PMID 32162278›Full record

Trial reportSleep & breathing = Schlaf & Atmung2020

A stepwise titration protocol for oral appliance therapy in positional obstructive sleep apnea patients: proof of concept.

M H T de Ruiter, G Aarab, N de Vries, F Lobbezoo, J de Lange

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyObservational StudyRandomized Controlled Trial
In one paragraph

Trial report in Sleep & breathing = Schlaf & Atmung, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06612008 (Superimposition of Intra-oral Scans in Mandibular Advancement Device), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.6field-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.

NCT06612008 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Superimposition of Intra-oral Scans in Mandibular Advancement Device (MAD) Therapy for Obstructive Sleep Apnea

TypeobservationalSponsorAmsterdam UMC, location VUmcRan2025 to 2029Enrolled250ConditionsObstructive Sleep ApneaArmsMandibular Advancement Device
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
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  3. Article
  4. Mandibular advancement devices in obstructive sleep apnea: diagnostic predictors for treatment response and clinical implications : A retrospective pilot cohort study.Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie · 2025
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  5. Review
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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

5 authors at 2 institutions in 2 countries.

M H T de RuiterDepartment of Oral and Maxillofacial Surgery of the Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. m.h.deruiter@amsterdamumc.nl.
G AarabDepartment of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
N de VriesDepartment of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
F LobbezooDepartment of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
J de LangeDepartment of Oral and Maxillofacial Surgery of the Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.
University of Amsterdam · NLAcademic Center for Dentistry Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn patients with positional obstructive sleep apnea (POSA), oral appliance therapy (OAT) is among the first-line treatments. The aim of this study was to evaluate the effects of a new standardized stepwise titration protocol for OAT in a group of patients with POSA.

methodsThis was an observational intervention trial. Patients who were previously randomized to the OAT intervention arm of a comparison study comprised the subjects for this study. These patients, who had mild to moderate POSA, were assessed after 3 and 12 months for treatment efficacy, objective adherence by temperature microsensor, and side effects. The titration of OAT was performed using a standardized stepwise titration protocol including advancement levels of 60%, 75%, and 90% of the maximum mandibular protrusion. The optimal advancement level per individual was based on a weighted compromise between efficacy and side effects.

resultsIn total, 36 patients were included and all completed the titration protocol after 3 months. At baseline, the OAT was set at 60% of the maximal mandibular protrusion position. At a 3-month evaluation, the advancement remained at 60% in 16 patients (44%) and reached 75% advancement in 20 patients (56%). Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months. The 12-month analysis showed consistent results and good OAT tolerance. Six patients (16.7%) terminated OAT and one patient (2.8%) was lost to follow-up.

conclusionsThis standardized stepwise titration protocol for OAT showed good efficacy, good OAT tolerance, and good objective adherence in patients with mild to moderate POSA. Therefore, the protocol is recommended in research projects to improve standardization of methods between studies and in clinical practice for its practical feasibility.

Indexed as

Outcome Assessment, Health CareAdultClinical ProtocolsFemaleHumansMaleMandibular AdvancementMiddle AgedProof of Concept StudySeverity of Illness IndexSleep Apnea, ObstructiveMandibular advancement deviceObstructive sleep apneaOral appliance therapyProtrusionSleep-disordered breathingTitration protocol

Identifiers

PMID32162278
PMCPMC7426292
OpenAlexW3012480007

What OpenQuestion holds

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LicenceCC BY
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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.