Evidence map›Paper›PMID 26241460›Full record

Trial reportMedicina oral, patologia oral y cirugia bucal2015

Efficacy of mandibular advancement device in the treatment of obstructive sleep apnea syndrome: A randomized controlled crossover clinical trial.

Joaquín Durán-Cantolla, Rafael Crovetto-Martínez, Mohammad-Hamdan Alkhraisat, Miguel Crovetto, Antonio Municio, Ramón Kutz, Felipe Aizpuru, Erika Miranda, Eduardo Anitua

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Medicina oral, patologia oral y cirugia bucal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 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.

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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Redefining Obstructive Sleep Apnea: Treatment in the Modern Era.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026
    Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Update on oral appliance therapy.European respiratory review : an official journal of the European Respiratory Society · 2019
    Review
  15. Review
  16. Update on Oral Appliance Therapy for OSA.Current sleep medicine reports · 2017
    Review
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

9 authors.

Joaquín Durán-CantollaServicio de Investigación, Instituto de Investigación BioAraba, Hospital Universitario Araba, C, José Achotegui sn, Planta 4 C, despacho 417, Vitoria-Gasteiz 01009, Spain, joaquin.durancantolla@gmail.com.
Rafael Crovetto-Martínez
Mohammad-Hamdan Alkhraisat
Miguel Crovetto
Antonio Municio
Ramón Kutz
Felipe Aizpuru
Erika Miranda
Eduardo Anitua

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvaluation of the efficacy and safety of a mandibular advancement device (MAD) (KlearwayTM) in the treatment of mild-to-moderate obstructive sleep apnea and chronic roncopathy. MATERIAL AND

methodsA randomized, placebo-controlled, double blinded, and crossover clinical trial was conducted. Placebo device (PD) defined as a splint in the centric occlusion that did not induce a mandibular advancement served as a control. The mandible was advanced to the maximum tolerable distance or to a minimum of 65% of the maximum protrusion. After each sequence of treatment, patients were assessed by questionnaires, conventional polysomnography, and objective measurement of snoring at the patient's own home.

resultsForty two patients participated in the study and 38 completed the study. Patients mean age was 46 ±9 years and the 79% were males. The mean mandibular advancement was 8.6 ±2.8 mm. Patients used the MAD and the PD for 6.4 +2.4 hours and 6.2 +2.0 hours, respectively. Secondary effects (mostly mild) occurred in the 85.7% and the 86.8% of the users of MAD and PD, respectively. The MAD induced a decrease in the apnea-hypopnea index (AHI) from 15.3 +10.2 to 11.9 +15.5. The 50% reduction in the AHI was achieved in the 46.2% and the 18.4% of the patients treated with MAD and PD, respectively. The use of the MAD induced a reduction in the AHI by 3.4 +15.9 while the PD induced an increase by 10.6 +26.1. The subjective evaluation of the roncopathy indicated an improvement by the MAD and an increase in the perceptive quality of sleep. However, the objective evaluation of the roncopathy did not show significant improvements.

conclusionsThe use of MAD is efficient to reduce the AHI and improve subjectively the roncopathy. MAD could be considered in the treatment of mild-to-moderate OSA and chronic roncopathy.

Indexed as

Cross-Over StudiesDouble-Blind MethodFemaleHumansMaleMandibular AdvancementMiddle AgedSeverity of Illness IndexSleep Apnea, ObstructiveTreatment Outcome

Identifiers

PMID26241460
PMCPMC4598931

What OpenQuestion holds

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Registered trials

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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.