Maxillary Expansion Effects in Children With Upper Airway Obstruction

Study Overview
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Brief Summary
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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.

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

Conditions
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Airway Obstruction

Intervention / Treatment
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* Procedure: Rapid maxillary expansion
* Procedure: Adenotonsillectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>Patients with atresic maxilla without upper airway obstruction submitted to rapid maxillary expansion | Procedure: Rapid maxillary expansion<br>* Device<br>* Other names: maxillary expansion;|
| Experimental: group 2<br>Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy | Procedure: Rapid maxillary expansion<br>* Device<br>* Other names: maxillary expansion;Procedure: Adenotonsillectomy<br>* Surgery<br>|
| Experimental: group 3<br>Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy | Procedure: Rapid maxillary expansion<br>* Device<br>* Other names: maxillary expansion;Procedure: Adenotonsillectomy<br>* Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway Volume | cone beam computed tomography | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life before and after maxillary expansion: | Obstructive 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). | 1 and 7 months | 
| Pediatric Quality of Life | Pediatric Quality of Life Inventory: 0-100 scale range. Higher scores indicate better HRQOL (Health-Related Quality of Life) | 1 and 7 months | 
| Sleep Disturbance for Children | Sleep Disturbance Scale for Children: scale range 26-130.Scores higher than 39 indicate sleep disturbance | 1 and 7 months | 
| Nasal septum morphology | Linear parameters by lateral tomographic distances | 7 months | 
| Dental arch distances | Dental arch growth as described by Mc Namara,2003 | 7 months | 
| Airway obstruction | Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy | 7 months | 
| Bruxism | Bruxism episodes | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maxillary expansion, adenotonsillar hypertrophy, airway volume