Maxillary Expansion Effects in Children With Upper Airway Obstruction

Not Applicable

• Conditions: Airway Obstruction
• Interventions: Procedure: Rapid maxillary expansion; Procedure: Adenotonsillectomy

• Registration Number: NCT03004300
• Lead Sponsor: Universidade Federal de Goias

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-28
• Study Start: 2017-07-13
• Primary Completion: 2019-03-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-16
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	Rapid maxillary expansion	Patients with atresic maxilla without upper airway obstruction submitted to rapid maxillary expansion
group 2	Rapid maxillary expansion	Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy
group 3	Adenotonsillectomy	Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy
group 2	Adenotonsillectomy	Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy
group 3	Rapid maxillary expansion	Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy

Primary Outcome Measures

Name	Time	Method
Airway Volume	7 months	cone beam computed tomography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculdade de Odontologia; 🇧🇷 Goias, Goiás, Brazil