Maxillary Expansion Effects in Children With Upper Airway Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-13

Study Completion Date

2020-03-31

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.

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Detailed Description

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Conditions

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Airway Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group 1

Patients with atresic maxilla without upper airway obstruction submitted to rapid maxillary expansion

Group Type ACTIVE_COMPARATOR

Rapid maxillary expansion

Intervention Type PROCEDURE

Device

group 2

Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy

Group Type EXPERIMENTAL

Rapid maxillary expansion

Intervention Type PROCEDURE

Device

Adenotonsillectomy

Intervention Type PROCEDURE

Surgery

group 3

Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy

Group Type EXPERIMENTAL

Rapid maxillary expansion

Intervention Type PROCEDURE

Device

Adenotonsillectomy

Intervention Type PROCEDURE

Surgery

Interventions

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Rapid maxillary expansion

Device

Intervention Type PROCEDURE

Adenotonsillectomy

Surgery

Intervention Type PROCEDURE

Other Intervention Names

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maxillary expansion

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes