Randomized controlled study of an oral jaw-positioning appliance for the treatment of obstructive sleep apnea in children with malocclusion
Abstract
To evaluate the clinical usefulness and tolerability of an oral jaw-positioning appliance in the treatment of obstructive sleep apnea syndrome in children, we studied 32 patients (mean age, 7.1 +/- 2.6 yr; 20 males) with symptoms of obstructive sleep apnea, malocclusion, and a baseline apnea index > 1 event/h. A group of 19 subjects was randomly assigned to a 6-mo trial of an oral appliance; the remainder acted as control subjects. At baseline and after the trial all patients underwent physical examination, a standard polysomnography, and orthodontic assessment. A modified version of the Brouillette questionnaire related to obstructive sleep apnea symptoms was administered to parents before and after the trial and a clinical score was calculated. Of the 32 subjects enrolled, 4 treated subjects and 5 control subjects were lost to follow-up. Polysomnography after the trial showed that treated subjects all had significantly lower apnea index (p < 0.001) and hypopnea index values (p < 0.001) than before the trial, whereas in untreated control subjects these values remained almost unchanged. Clinical assessment before and after treatment showed that in 7 of the 14 subjects (50%) the oral appliance had reduced (a fall of at least 2 points in the respiratory score) and in 7 had resolved the main respiratory symptoms, whereas untreated patients continued to have symptoms. In conclusion, treatment of obstructive sleep apnea syndrome with an oral appliance in children with malocclusion is effective and well tolerated.
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Villa et al. included children with adenotonsillar hypertrophy and observed an improvement in apnea-hypopnea index from 7.1 to 2.6 per hour, as well as a reduction in adenotonsillar hypertrophy after 6 months.
“Villa et al 22 included children with adenotonsillar hypertrophy and they still observed an improvement in the AHI, from 7.1 to 2.6/h, as well as a reduction in adenotonsillar hypertrophy after 6 months. 22”
From Mandibular Advancement Appliances in Pediatric Obstructive Sleep Apnea: An Umbrella Review (2023) · cites this paper as [22]
Another randomized controlled trial was assessed as at high risk of bias because it used a quasi-random method of allocation (alphabetically by surname) and the percentage of dropouts was higher than 20%.
“And another RCT [26] was assessed as at high risk of bias because they used a quasi-random method of allocation (alphabetically by surname), and the percentage of dropouts was higher than 20%.”
From Mandibular advancement appliances for the treatment of obstructive sleep apnea in children: a systematic review and meta-analysis (2019) · cites this paper as [26]
Oxygen desaturation index decreased but showed no significant difference in two randomized controlled trials.
“Oxygen desaturation index (ODI) decreased but showed no significant difference in two RCTs [26,32].”
From Mandibular advancement appliances for the treatment of obstructive sleep apnea in children: a systematic review and meta-analysis (2019) · cites this paper as [26]
In a sensitivity analysis including the quasi-randomized RCT, the mean difference in AHI change for mandibular advancement appliance compared with control remained stable at -1.79 events/h (95% CI -2.10 to -1.48, p < 0.00001).
“The results remained stable, and DAHI for MAA compared with control was À1.79 events/h, (95% CI -2.10, À1.48), p < 0.00001 (see Fig. 5).”
From Mandibular advancement appliances for the treatment of obstructive sleep apnea in children: a systematic review and meta-analysis (2019) · cites this paper as [26]
The lowest oxygen saturation showed a significant increase in two included studies, whereas there was no significant difference in another two included studies.
“The lowest oxygen saturation (minSaO 2 ) showed a significant increase in two studies [32,37] whereas there was no significant difference in another two [26,34].”
From Mandibular advancement appliances for the treatment of obstructive sleep apnea in children: a systematic review and meta-analysis (2019) · cites this paper as [26]
In included studies, daytime and night-time symptoms related to obstructive sleep apnea diminished in treated subjects, and Epworth sleepiness scale and pediatric sleep questionnaire scores decreased.
“Symptoms related to OSA were evaluated by variable questionnaires: daytime symptoms (sleepiness, irritability, tiredness, oral breathing, nasal stuffiness) and night-time symptoms (habitual snoring, restless sleep) in treated subjects diminished [26], Epworth sleepiness scale (ESS) and pediatric sleep questionnaire (PSQ) scores decreased [32,34].”
From Mandibular advancement appliances for the treatment of obstructive sleep apnea in children: a systematic review and meta-analysis (2019) · cites this paper as [26]
At the time of the previous Cochrane review, there was not enough high-quality evidence to affirm that oral appliances and functional orthopedic appliances are effective in the treatment of obstructive sleep apnea in children.
“At that time, there was not enough high-quality evidence to affirm that oral appliances and functional orthopedic appliances are effective in the treatment of OSA in children [26].”
From Mandibular advancement appliances for the treatment of obstructive sleep apnea in children: a systematic review and meta-analysis (2019) · cites this paper as [26]
FOA would also treat OSA because they promote mandibular replacement during sleep and increase the retroglossal space by anterior displacement of the tongue, improving respiratory function, especially at night.
“Villa et al. in 200223 reports that, in addition to treating the craniofacial problem, FOA would also be treating OSA because they promote mandibular replacement during sleep and increase the retroglossal space by anterior displacement of the tongue, improving respiratory function, especially at night.”
From Effectiveness of functional orthodontic appliances in obstructive sleep apnea treatment in children: literature review (2022) · cites this paper as [23]
Several randomized clinical trials suggest that orthodontic treatments, such as mandibular advancement with functional appliances, can be effective in the management of pediatric snoring and OSA.
“Several randomized clinical trials23, 24, 25 suggest that orthodontic treatments, such as mandibular advancement with functional appliances, can be effective in the management of pediatric snoring and OSA.”
From Effectiveness of functional orthodontic appliances in obstructive sleep apnea treatment in children: literature review (2022) · cites this paper as [23]
Early treatment of craniofacial abnormalities can prevent the development of long-term respiratory failure, impacting quality of life in adulthood.
“Therefore, early treatment of craniofacial abnormalities can prevent the development of long-term respiratory failure, impacting the quality of life in adulthood.23, 34, 39, 40, 41”
From Effectiveness of functional orthodontic appliances in obstructive sleep apnea treatment in children: literature review (2022) · cites this paper as [23]
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“The second focuses on functional outcomes measured by polysomnography, where reductions in AHI and improvements in oxygenation have been reported in selected cohorts, but durable normalization across the growth period remains inconsistent [10, 18, 39, 45, 46].”
- Authors
- Villa, M. P., Bernkopf, E., Pagani, J., Broia, V., Montesano, M., & Ronchetti, R.
- Affiliations
- Sapienza University of Rome (IT)
- Venue
- American Journal of Respiratory and Critical Care Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2002-01-01
- Volume
- 165
- Issue
- 1
- Pages
- 123-127
- ISSN
- 1073-449X (ISSN-L)
- 1535-4970
- OpenAlex
- W2133591042
- Cited by
- 233
- References
- 24
- Citations by year
- 2026: 5 · 2025: 6 · 2024: 7 · 2023: 8 · 2022: 9 · 2021: 11 · 2020: 4 · 2019: 17 · 2018: 14 · 2017: 19 · 2016: 16 · 2015: 10 · 2014: 10 · 2013: 11 · 2012: 11
- FWCI
- 4.13
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Respiratory and Critical Care Medicine (publishedVersion)
- PubMed (publishedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
- Health Sciences › Health Professions › Complementary and Manual Therapy › Temporomandibular Joint Disorders
- Health Sciences › Dentistry › Orthodontics › Orthodontics and Dentofacial Orthopedics
- Keywords
- obstructive sleep apnea, children, malocclusion, oral appliances, mandibular advancement device, apnea index, hypopnea, polysomnography, orthodontic appliances, treatment tolerability
- MeSH terms
- Anthropometry, Child, Child, Preschool, Female, Follow-Up Studies, Humans, Male, Malocclusion, Orthodontic Appliances, Removable, Surveys and Questionnaires, Severity of Illness Index, Treatment Outcome, Occlusal Splints, Polysomnography, Sleep Apnea, Obstructive
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