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Cited by 31Obstructive Sleep Apnea ResearchOrthodontics and Dentofacial OrthopedicsTemporomandibular Joint Disorders

Randomized controlled study of a mandibular advancement appliance for the treatment of obstructive sleep apnea in children: A pilot study

Open access
Machado-Junior, AJ, Signorelli, LG, Zancanella, E, Crespo, AN·2016·Medicina Oral Patología Oral y Cirugia Bucal
DOI 10.4317/medoral.21072PMC PMC4920451
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Abstract

BACKGROUND: The current limited evidence may be suggestive that mandibular advancement appliance (MAAs) result in improvements in AHI scores, but it is not possible to conclude that MAAs are effective to treat paediatric OSA.There are significant weaknesses in the existing evidence due primarily to absence of control groups, small sample sizes, lack of randomization and short-term results. AIM: the objective of the present study was to evaluate MAAs in children with OSA. METHODS: Children presenting an apnea-hypopnea index (AHI) greater than or equal to one event per hour were considered to be apneic. This group of children with AHI greater than or equal to one was randomly divided through a draw into two subgroups: half of them in an experimental subgroup and half of them in a control subgroup. In the experimental subgroup, molds of each of these children's maxillary and mandibular arches were taken using standard molds and molding material. The control group did not use any intraoral device and did not undergo any type of treatment for OSAS. The MAAs used in this study had the aim of achieving mandibular advancement, thereby correcting the mandibular position and dental occlusion, and perhaps increasing the airway and treating OSAS. After 12 consecutive months of use of the mandibular advancement devices, polysomnography examinations using the same parameters as in the initial examinations were requested for both the experimental and the control subgroup. RESULTS: There was a decrease in AHI in the experimental group and an increase in the control group, with statistical significance. These data were used to calculate the sample size, which was 28 children in total in the groups. CONCLUSIONS: There was a decrease in AHI one year after implementing use of mandibular advancement devices, in comparison with the group that did not use these devices.

AI snapshot

Written from the paper’s full text.

TL;DR

In a randomized pilot of children with AHI ≥1 event/hour and mandibular retrusion, 12 months of a mandibular advancement appliance was associated with decreased AHI, while the no-treatment control group showed increased AHI. The authors conclude the appliance reduced AHI versus no device, but emphasize the small sample and need for larger, longer studies.

Key findings

  • Sixteen children with AHI ≥1 event/hour were randomized: 8 to mandibular advancement appliance and 8 to no device/no OSAS treatment. After 12 months, repeat polysomnography was available for 8 experimental and 6 control children, with 2 control losses.
  • AHI decreased in the experimental group and increased in the control group, with statistical significance; the mean initial AHI of the sample was 1.8.
  • These data were used to calculate a sample size of 28 children total in the groups for future studies.
  • The authors conclude there was a decrease in AHI one year after implementing mandibular advancement devices, compared with the group that did not use these devices.

Methods

  • Randomized controlled prospective clinical trial. Children from a school in Campinas, in mixed dentition, with clinical mandibular retrusion and OSAS symptoms, were referred for full nighttime polysomnography. AHI ≥1 event/hour was considered apneic. Of 97 polysomnographies, 7 were excluded for recording failures; among the remaining 90, 16 had AHI ≥1 and were included and randomly divided by draw/table system into experimental and control subgroups.
  • Experimental subgroup received custom mandibular advancement devices based on modified Planas principles: two acrylic plates, occlusal tracks, a Cofen spring, anti-labial components, a 1.2-mm telescopic tube, and a 0.7-mm guidewire. Devices were to be used at all times except meals and cleaning, with monthly check-ups. Control group received no intraoral device and no OSAS treatment. After 12 consecutive months, repeat polysomnography used the same parameters; the reader was blinded to group.
  • Analysis compared groups and times of AHI measurements using ANOVA for repeated measurements, plus sample size calculation. Exclusions included craniofacial malformation, prognathism, obesity, previous orthodontic or orthopedic treatment, prior phonotherapeutic treatment, or otorhinolaryngological surgery.

Limitations

  • The paper states the small sample size was a limitation, and that the data were used to calculate an ideal sample size for new studies. It also states there are no studies on mandibular advancement devices with longer follow-ups and that long-term effects need evaluation.
  • The paper states it only evaluated patients with retrognathism and excluded children who were obese or had undergone otorhinolaryngological surgery; new studies are needed in those excluded groups. It also notes no consensus on daily duration or total length of appliance use, and that adherence gradually decreased over months.
  • Evident from the text: this was a pilot with only 16 randomized children and 14 with follow-up polysomnography due to 2 control losses; the baseline mean AHI was low (1.8), and the text reports statistical significance without p-values or effect sizes.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.4317/medoral.21072

Cites

14 of 14 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 23 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    The mean AHI of the sample at baseline was 1.8.

    “The mean AHI of the sample was initially 1.8.”
    Quote in the paperNot a substantial claim
  • Findingown data

    Before twelve months of use, mandibular advancement had already taken place.

    “we observed that before this length of time had been reached, the mandibular advancement had already taken place.”
    Quote in the paperNot a substantial claim
  • Findingown data

    The longer the daily period of use, the faster the mandibular advancement.

    “We observed that the longer the daily period of use was, the faster the mandibular advancement was.”
    Quote in the paperNot a substantial claim
  • Interpretationown data

    When mandibular advancement devices are properly indicated, they may be more than coadjuvants in treating childhood OSAS.

    “Nonetheless, we believe and our results indicate that when mandibular advancement devices are properly indicated, they may be more than coadjuvants in treating childhood OSAS.”
    Quote in the paperSubstantial claim
  • Study design and conductnone given

    One limitation of the study was its small sample size.

    “One of the limitations of the present study was the small sample size, but we used these data to make a sample size calculation, which indicates what the ideal sample size would be for new studies of this type on childhood OSAS.”
    Quote in the paperSubstantial claim
  • May combine two claims. 12
  • The quote only partly states this claim. 1
  • Classified as probably not a substantial claim. 8

  • May combine two claims.

    Findingown data

    Between March 2013 and February 2014, 97 children fulfilled inclusion criteria and underwent polysomnography; 7 were excluded due to recording failures, and 16 with AHI greater than or equal to one event per hour were included.

    “Between March 2013 and February 2014, 97 children who fulfilled the inclusion criteria underwent polysomnography examinations at the outpatient clinic of the university hospital of Unicamp (Campinas State University) - São Paulo - Brazil. Out of the 97 polysomnography examinations, the results from seven of them could not be used because of failures in recording the examination, and these ExaminAt”
    • Also stated in: § Results · plain
      “Among the remaining 90 examinations, 16 presented AHI greater than or equal to one event per hour and were included in this study.”
    Quote in the paperSubstantial claim

  • May combine two claims. The quote only partly states this claim.

    Findingown data

    In children with OSAS and mandibular retrusion, after 12 months, the apnea-hypopnea index decreased in the mandibular advancement appliance group and increased in the control group, with a statistically significant difference between groups.

    “There was a decrease in AHI in the experimental group and an increase in the control group, with statistical significance (Fig. 1).”
    • Also stated in: § Conclusions · plain
      “There was a decrease in AHI one year after implementing use of mandibular advancement devices, in comparison with the group that did not use these devices.”
    • Also stated in: § Discussion · boosted
      “The results from this study demonstrate that there was a decrease in AHI after the mandibular advancement devices had been used and an increase in this index in the control group.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Adherence to treatment was good, especially during the initial months, but gradually decreased over the months.

    “We observed that there was good adherence to treatment, especially during the initial months with the device installed. However, this adherence gradually decreased over the course of the months.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    Post-treatment polysomnography examinations used the same parameters as the initial examinations.

    “After 12 consecutive months of use of the mandibular advancement devices, polysomnography examinations using the same parameters as in the initial examinations were requested for both the experimental and the control subgroup.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Mandibular advancement appliances have been used to treat OSAS among children, but only a small number of studies have evaluated this method and there is no consensus regarding their use.

    “Among the intra-oral devices, mandibular advancement appliances (MAAs) has been used to treat OSAS among children (5-10), although only a small number of studies have evaluated using this method for OSAS and there is no consensus with regard to using MAAs (5,6).”
    Quote in the paperSubstantial claim0 of 6 sources checked
    • cites [5] Carvalho FR Lentini-Oliveira D Machado MA Prado GF Prado LB Saconato H Oral appliances and functional orthopaedic appliances for obstructive sleep apnoea in children Cochrane Database Syst Rev 2007 2 CD005520 17443598

      Not checked in the free run.

    • cites [6] Nazarali N Altalibi M Nazarali S Major MP Flores-Mir C Major PW Mandibular advancement appliances for the treatment of paediatric obstructive sleep apnea: a systematic review Eur J Orthod 2015 37 618 26 25681125

      Not checked in the free run.

    • cites [7] Villa MP Bernkopf E Pagani J Broia V Montesano M Ronchetti R Randomized controlled study of an oral jaw-positioning appliance for the treatment of obstructive sleep apnea in children with malocclusion Am J Respir Crit Care Med 2002 165 123 7 11779741

      Not checked in the free run.

    • cites [8] Cozza P Polimeni A Ballanti F A modified monobloc for the treatment of obstructive sleep apnoea in paediatric patients Eur J Orthod 2004 26 523 30 15536841

      Not checked in the free run.

    • cites [9] Schütz TC Dominguez GC Hallinan MP Cunha TC Tufik S Class II correction improves nocturnal breathing in adolescents Angle Orthod 2011 81 222 8 21208073 PMC8925255

      Not checked in the free run.

    • cites [10] Zhang C He H Ngan P Effects of twin block appliance on obstructive sleep apnea in children: a preliminary study Sleep Breat 2013 17 1309 14 23558604

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Adenotonsillectomy and, in selected cases, CPAP have been the preferred treatments for OSAS in children, but without absolute success.

    “Adenotonsillectomy and, in selected cases, continuous positive airway pressure (CPAP) have been the preferred treatments for OSAS in children, but without having absolute success in treating this syndrome (1-5).”
    Quote in the paperSubstantial claim0 of 5 sources checked
    • cites [1] Marcus CL Brooks LJ Draper KA Gozal D Halbower AC Jones J Diagnosis and management of childhood obstructive sleep apnea syndrome Pediatrics 2012 130 576 84 22926173

      Not checked in the free run.

    • cites [2] Villa MP Miano S Rizzoli A Mandibular advancement devices are an alternative and valid treatment for pediatric obstructive sleep apnea syndrome Sleep Breath 2012 16 971 6 21948042

      Not checked in the free run.

    • cites [3] Camacho M Certal V Abdullatif J Zaghi S Ruoff CM Capasso R Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis Sleep 2015 38 669 75 25348130 PMC4402674

      Not checked in the free run.

    • cites [4] Tan HL Kheirandish-Gozal L Abel F Gozal D Craniofacial syndromes and sleep-related breathing disorders Sleep Med Rev 2016 27 74 88 26454241 PMC5374513

      Not checked in the free run.

    • cites [5] Carvalho FR Lentini-Oliveira D Machado MA Prado GF Prado LB Saconato H Oral appliances and functional orthopaedic appliances for obstructive sleep apnoea in children Cochrane Database Syst Rev 2007 2 CD005520 17443598

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductown data

    After one year, polysomnography was performed on eight children in the experimental group and six in the control group, with a sample loss of two children in the control group.

    “The examination was performed on eight children in the experimental group and on six children in the control group, with a sample loss of two children in the control group.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    A recent review identified only four studies of children with OSAS and mandibular advancement devices and concluded they were insufficient to state that the therapy was effective against OSAS during childhood.

    “A recent review study only identified four studies that involved samples of children with OSAS and mandibular advancement devices (4). It was concluded that these studies were insufficient to be able to state that this therapy was effective against OSAS during childhood (6).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [4] Tan HL Kheirandish-Gozal L Abel F Gozal D Craniofacial syndromes and sleep-related breathing disorders Sleep Med Rev 2016 27 74 88 26454241 PMC5374513

      Not checked in the free run.

    • cites [6] Nazarali N Altalibi M Nazarali S Major MP Flores-Mir C Major PW Mandibular advancement appliances for the treatment of paediatric obstructive sleep apnea: a systematic review Eur J Orthod 2015 37 618 26 25681125

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductown data

    The study was a randomized controlled prospective clinical trial.

    “This was a randomized controlled prospective clinical trial.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductcitation

    The children with AHI greater than or equal to one event per hour were randomly divided by a draw into an experimental subgroup and a control subgroup.

    “This group of children with AHI greater than or equal to onewas randomly (table system) (11) divided through a draw into two subgroups: half of them in an experimental subgroup and half of them in a control subgroup.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [11] Altman DG Better reporting of randomized controlled trials: the CONSORT statement BMJ 1996 313 570 1 8806240 PMC2352018

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    Patients with craniofacial malformation, prognathism, obesity, previous orthodontic or orthopedic treatment, phonotherapeutic treatment, or otorhinolaryngological surgery were excluded.

    “Patients presenting craniofacial malformation, prognathism, obesity or previous orthodontic or orthopedic treatment were excluded from the sample. Likewise, patients who had undergone phonotherapeutic treatment or otorhinolaryngological surgery prior to this study were also excluded from the sample.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Current limited evidence may suggest that mandibular advancement appliances improve AHI scores, but it is not possible to conclude that they are effective for treating paediatric OSA.

    “The current limited evidence may be suggestive that MAAs result in improvements in AHI scores, but it is not possible to conclude that MAAs are effective to treat paediatric OSA (5,6).”
    • Also stated in: § Background · hedged
      “The current limited evidence may be suggestive that mandibular advancement appliance (MAAs) result in improvements in AHI scores, but it is not possible to conclude that MAAs are effective to treat paediatric OSA.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [5] Carvalho FR Lentini-Oliveira D Machado MA Prado GF Prado LB Saconato H Oral appliances and functional orthopaedic appliances for obstructive sleep apnoea in children Cochrane Database Syst Rev 2007 2 CD005520 17443598

      Not checked in the free run.

    • cites [6] Nazarali N Altalibi M Nazarali S Major MP Flores-Mir C Major PW Mandibular advancement appliances for the treatment of paediatric obstructive sleep apnea: a systematic review Eur J Orthod 2015 37 618 26 25681125

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductown data

    The researcher who read the polysomnograms was blinded to the group allocation of each child.

    “The researcher who read the polysomnograms was kept unaware of the group to which each child belonged and from which child each examination came, so as to avoid bias.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The study data were used to calculate a sample size of 28 children in total for the groups.

    “These data were used to calculate the sample size, which was 28 children in total in the groups ( Table 2).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    The study was approved by the research ethics committee and parents/caretakers signed a consent form.

    “This study was previously approved by the research ethics committee of the institution where it was conducted: Discipline of Otorhinolaryngology- Medicine School - Unicamp (Campinas State University) - São Paulo - Brazil. Parents and caretakers signed consent form.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    OSAS during childhood leads to significant physical and neuropsychomotor impairment and needs to be recognized and treated early.

    “OSAS during childhood leads to significant physical and neuropsychomotor impairment. Thus, it needs to be recognized and treated early on, in an attempt to avoid or attenuate its consequences, which are very deleterious to proper child development (3,4).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [3] Camacho M Certal V Abdullatif J Zaghi S Ruoff CM Capasso R Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis Sleep 2015 38 669 75 25348130 PMC4402674

      Not checked in the free run.

    • cites [4] Tan HL Kheirandish-Gozal L Abel F Gozal D Craniofacial syndromes and sleep-related breathing disorders Sleep Med Rev 2016 27 74 88 26454241 PMC5374513

      Not checked in the free run.

  • May combine two claims.

    Study design and conductown data

    The mean age at initial examination was 8.13 years in the experimental group and 8.39 years in the control group, with no significant difference.

    “The mean age of the children at the time of the initial examination was 8.13 years in the experimental group and 8.39 years in the control group, without any significant difference.”
    Quote in the paperNot a substantial claim
17 of 17

  • The paper relies on this without support.

    The present study is possibly the first randomized controlled trial of mandibular advancement appliances for pediatric OSAS.

    “Our study is possibly the first randomized controlled trial.”
1 of 1

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Mandibular advancement appliances may decrease the intraoral space for the tongue, which can be displaced backwards, leading to a collapse of the tongue base.

    “Another aspect that should be considered is that MAAs may decrease the intraoral space for the tongue, which can be displaced backwards, leading to a collapse of the tongue base.”

    From Mandibular Advancement Appliances in Pediatric Obstructive Sleep Apnea: An Umbrella Review (2023) · cites this paper as [24]

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Related

Authors
Machado-Junior, A., Signorelli, L., Zancanella, E., & Crespo, A.
Affiliations
Universidade Estadual de Campinas (UNICAMP) (BR)
ORCID
Zancanella, E
Venue
Medicina Oral Patología Oral y Cirugia Bucal
Publisher
Medicina Oral, S.L.
Published
2016
Volume
21
Issue
4
Pages
0-0
ISSN
  • 1698-4447 (ISSN-L)
  • 1698-6946
DOI
10.4317/medoral.21072
PMC
PMC4920451
OpenAlex
W2294063271
Semantic Scholar
bf29dd4bc455b838648c2e7bb12f482866df1293
Cited by
30
References
14
Citations by year
2026: 1 · 2025: 5 · 2024: 4 · 2023: 5 · 2022: 4 · 2021: 5 · 2020: 2 · 2019: 2 · 2018: 1 · 2016: 1
FWCI
1.07
Type
journal article
Language
en
Open access
Locations
  • Medicina oral, patología oral y cirugía bucal (publishedVersion)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Repository of Digital Objects for Teaching Research and Culture (University of Valencia) (submittedVersion, cc-by-nc)
Funders
Fundação de Amparo à Pesquisa do Estado de São Paulo
Topics
  • Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
  • Health Sciences › Dentistry › Orthodontics › Orthodontics and Dentofacial Orthopedics
  • Health Sciences › Health Professions › Complementary and Manual Therapy › Temporomandibular Joint Disorders
Keywords
mandibular advancement device, obstructive sleep apnea, pediatric sleep apnea, apnea-hypopnea index, oral appliance therapy, mandibular advancement, airway obstruction, dental occlusion, polysomnography
MeSH terms
Child, Dental Occlusion, Humans, Pilot Projects, Treatment Outcome, Polysomnography, Mandibular Advancement, Sleep Apnea, Obstructive

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