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

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.

Study Overview

• Status: Unknown
• Conditions: Airway Obstruction
• Intervention / Treatment: Procedure: Rapid maxillary expansion; Procedure: Adenotonsillectomy

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Goiás
    • Goias, Goiás, Brazil, 74.605-220
      • Faculdade de Odontologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal de Goias
• Investigators: Principal Investigator: Jose Valladares Neto, PHD, Universidade Federal de Goias

Publications and helpful links

General Publications

• Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
• Guilleminault C, Monteyrol PJ, Huynh NT, Pirelli P, Quo S, Li K. Adeno-tonsillectomy and rapid maxillary distraction in pre-pubertal children, a pilot study. Sleep Breath. 2011 May;15(2):173-7. doi: 10.1007/s11325-010-0419-3. Epub 2010 Sep 17.
• de Castilho LS, Abreu MH, de Oliveira RB, Souza E Silva ME, Resende VL. Factors associated with mouth breathing in children with -developmental -disabilities. Spec Care Dentist. 2016 Mar-Apr;36(2):75-9. doi: 10.1111/scd.12157. Epub 2016 Jan 13.
• Caprioglio A, Meneghel M, Fastuca R, Zecca PA, Nucera R, Nosetti L. Rapid maxillary expansion in growing patients: correspondence between 3-dimensional airway changes and polysomnography. Int J Pediatr Otorhinolaryngol. 2014 Jan;78(1):23-7. doi: 10.1016/j.ijporl.2013.10.011. Epub 2013 Oct 25.
• Chang Y, Koenig LJ, Pruszynski JE, Bradley TG, Bosio JA, Liu D. Dimensional changes of upper airway after rapid maxillary expansion: a prospective cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2013 Apr;143(4):462-70. doi: 10.1016/j.ajodo.2012.11.019.
• Bruni O, Ottaviano S, Guidetti V, Romoli M, Innocenzi M, Cortesi F, Giannotti F. The Sleep Disturbance Scale for Children (SDSC). Construction and validation of an instrument to evaluate sleep disturbances in childhood and adolescence. J Sleep Res. 1996 Dec;5(4):251-61. doi: 10.1111/j.1365-2869.1996.00251.x.
• Fernandes FM, Teles Rda C. Application of the Portuguese version of the Obstructive Sleep Apnea-18 survey to children. Braz J Otorhinolaryngol. 2013 Nov-Dec;79(6):720-6. doi: 10.5935/1808-8694.20130132.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2017
• Primary Completion (Actual): March 30, 2019
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 27, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: adenotonsillar hypertrophy; airway volume; maxillary expansion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: 044029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No