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Maxillary Expansion Effects in Children With Upper Airway Obstruction

Maxillary Expansion Effects in the Facial Structures of Children With Upper Airway Obstruction: a Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03004300
Enrollment
60
Registered
2016-12-28
Start date
2017-07-13
Completion date
2020-03-31
Last updated
2019-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Obstruction

Keywords

maxillary expansion, adenotonsillar hypertrophy, airway volume

Brief summary

The most frequent causes of mouth breathers are the adenotonsillar hypertrophy. Adenotonsillectomy is the main choice for the elimination of the obstruction. However, this surgical treatment does not have its effect well elucidated and apnea has been cited in the literature as a residual outcome. Other types of supporting treatment may also been involved such as the use of corticosteroids, physiotherapy and orthodontic-orthopedic treatment, among them rapid maxillary expansion (RME). RME corrects the morphological constriction of the upper arch caused by buccal breathing and also reduce the airway resistance. Despite reports of RME influencing volume enhancement in pharyngeal airway, there are still few three-dimensional studies following the post-expansion effects. In addition, these changes are doubtful due postural changes of the tongue during the tomography exam. Conflicts of results are also present for changes in the nasal septum of children. The main alteration mentioned is the increase in the length of the lower third of the septum. The investigators propose a randomized, prospective, controlled clinical trial in patients with atresic maxilla with or without adenotonsillar hypertrophy. The patients will be treated with RME and adenotonsillectomy when the obstruction is present. The purpose of this study is elucidate if there is different outcomes considering the moment of RME treatment before or after the adenotonsillectomy.

Interventions

PROCEDUREAdenotonsillectomy

Surgery

Sponsors

Universidade Federal de Goias
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

* Children (boys and girls) between 5 and 9 years of age. * Atresic maxilla. * Skeletal Class I * With or without Adenotonsillar hypertrophy * Parents or tutors sign Informed Consent.

Exclusion criteria

* Craniofacial syndromes or neurologic disease diagnosis. * History of adenotonsillectomy and orthodontic treatment * History of facial trauma * Morbid obesity * Premature loss of posterior teeth

Design outcomes

Primary

MeasureTime frameDescription
Airway Volume7 monthscone beam computed tomography

Secondary

MeasureTime frameDescription
Pediatric Quality of Life1 and 7 monthsPediatric Quality of Life Inventory: 0-100 scale range. Higher scores indicate better HRQOL (Health-Related Quality of Life)
Sleep Disturbance for Children1 and 7 monthsSleep Disturbance Scale for Children: scale range 26-130.Scores higher than 39 indicate sleep disturbance
Nasal septum morphology7 monthsLinear parameters by lateral tomographic distances
Quality of life before and after maxillary expansion:1 and 7 monthsObstructive Sleep Apnea-18 questionnaire (OSA-18: scale range 18-126. The impact on quality of life was classified in three groups: a) minor (scores below 60); b) moderate (scores between 60 and 80) and major (scores above 80).
Airway obstruction7 monthsAdenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy
Bruxism7 monthsBruxism episodes
Dental arch distances7 monthsDental arch growth as described by Mc Namara,2003

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026