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Maxillary Expansion Effects in Children With Upper Airway Obstruction

NCT03004300 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-16

No results posted yet for this study

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.

Conditions

  • Airway Obstruction

Interventions

PROCEDURE

Rapid maxillary expansion

Device

PROCEDURE

Adenotonsillectomy

Surgery

Sponsors & Collaborators

  • Universidade Federal de Goias

    lead OTHER

Principal Investigators

  • Jose Valladares Neto, PHD · Universidade Federal de Goiás

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-13
Primary Completion
2019-03-30
Completion
2020-03-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03004300 on ClinicalTrials.gov