Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2017
Ready-Made Versus Custom-Made Mandibular Repositioning Devices in Sleep Apnea: A Randomized Clinical Trial.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Factors influencing adherence to oral appliance therapy in adults 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 · 2021Pooled it
- Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022Trial
- Mandibular Advancement Device Treatment Efficacy Is Associated with Polysomnographic Endotypes.Annals of the American Thoracic Society · 2021Trial
- Most Custom Oral Appliances for Obstructive Sleep Apnea Do Not Meet the Definition of Custom.Bioengineering (Basel, Switzerland) · 2025Review
- Three Decades of Managing Pediatric Obstructive Sleep Apnea Syndrome: What's Old, What's New.Children (Basel, Switzerland) · 2025Review
- The role of orthodontists in the multidisciplinary management of obstructive sleep apnea.Progress in orthodontics · 2024Review
- Diagnostic and Therapeutic Indications of Different Types of Mandibular Advancement Design for Patients with Obstructive Sleep Apnea Syndrome: Indications from Literature Review and Case Descriptions.Diagnostics (Basel, Switzerland) · 2024Review
- Oral appliance therapy and hypoglossal nerve stimulation as non-positive airway pressure treatment alternatives for obstructive sleep apnea: a narrative expert review.Sleep advances : a journal of the Sleep Research Society · 2024Article
- Indications for Dental Specialists for Treating Obstructive Sleep Apnea with Mandibular Advancement Devices: A Narrative Review.International journal of dentistry · 2024Review
- Factors associated with treatment adherence to mandibular advancement devices: a scoping review.Sleep & breathing = Schlaf & Atmung · 2023Article
- Review
- The role of oral appliance therapy in obstructive sleep apnoea.European respiratory review : an official journal of the European Respiratory Society · 2023Review
- 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 · 2023Article
- Mandibular Advancement Splint Therapy.Advances in experimental medicine and biology · 2022Article
- Mandibular Advancement Devices for OSA: An Alternative to CPAP?Pulmonary therapy · 2021Review
- Review
- Oral Appliance Therapy for Obstructive Sleep Apnoea: State of the Art.Journal of clinical medicine · 2019Review
- Update on oral appliance therapy.European respiratory review : an official journal of the European Respiratory Society · 2019Review
- Phenotypic Labelling Using Drug-Induced Sleep Endoscopy Improves Patient Selection for Mandibular Advancement Device Outcome: A Prospective Study.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2019Article
- Comparative assessment of changes in pharyngeal airway space in cases of obstructive sleep apnoea with a customized mandibular repositioning appliance - a clinical study.Sleep science (Sao Paulo, Brazil)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesTo compare the effectiveness of a custom-made (MRDc) versus ready-made (MRDr) mandibular repositioning devices (MRD) in the management of obstructive sleep apnea (OSA).
methodsA randomized crossover trial design was adopted in which patients with a confirmed diagnosis of OSA were randomly allocated to receive either a 3-month period of ready-made or custom-made MRD, with an intervening washout period of 2 weeks, prior to crossover. Treatment outcomes included both objective sleep monitoring and patient-centered measures (daytime sleepiness, partner snoring and quality of life).
resultsTwenty-five patients, with a mild degree of OSA (apnea-hypopnea index of 13.3 [10.9-25] events/h) and daytime sleepiness (Epworth Sleepiness Scale of 11 [6-16]), completed both arms of the trial. The MRDc achieved a complete treatment response in 64% of participants, compared with 24% with the MRDr (p < 0.001). A significant difference was observed in treatment failures, when comparing the MRDr (36%) with the MRDc (4%). Excessive daytime sleepiness (Epworth Sleepiness Scale ≥ 10) persisted in 33% (MRDc) and 66% (MRDr) of OSA subjects, following treatment. A statistically significant improvement was observed in quality of life scales following MRDc therapy only. Significant differences were observed in relation to both the number of nights per week (p = 0.004) and hours per night (p = 0.006) between the two different designs of device.
conclusionsThe study demonstrates the significant clinical effectiveness of a custom-made mandibular repositioning device, particularly in terms of patient compliance and tolerance, in the treatment of OSA.
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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.