Maxillary Expansion Effects in Children With Upper Airway Obstruction
Primary Purpose
Airway Obstruction
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Rapid maxillary expansion
Adenotonsillectomy
Sponsored by
About this trial
This is an interventional treatment trial for Airway Obstruction focused on measuring maxillary expansion, adenotonsillar hypertrophy, airway volume
Eligibility Criteria
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
Sites / Locations
- Faculdade de Odontologia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
group 1
group 2
group 3
Arm Description
Patients with atresic maxilla without upper airway obstruction submitted to rapid maxillary expansion
Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy
Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy
Outcomes
Primary Outcome Measures
Airway Volume
cone beam computed tomography
Secondary Outcome Measures
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).
Pediatric Quality of Life
Pediatric Quality of Life Inventory: 0-100 scale range. Higher scores indicate better HRQOL (Health-Related Quality of Life)
Sleep Disturbance for Children
Sleep Disturbance Scale for Children: scale range 26-130.Scores higher than 39 indicate sleep disturbance
Nasal septum morphology
Linear parameters by lateral tomographic distances
Dental arch distances
Dental arch growth as described by Mc Namara,2003
Airway obstruction
Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy
Bruxism
Bruxism episodes
Full Information
NCT ID
NCT03004300
First Posted
December 22, 2016
Last Updated
October 14, 2019
Sponsor
Universidade Federal de Goias
1. Study Identification
Unique Protocol Identification Number
NCT03004300
Brief Title
Maxillary Expansion Effects in Children With Upper Airway Obstruction
Official Title
Maxillary Expansion Effects in the Facial Structures of Children With Upper Airway Obstruction: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 13, 2017 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Goias
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction
Keywords
maxillary expansion, adenotonsillar hypertrophy, airway volume
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
Patients with atresic maxilla without upper airway obstruction submitted to rapid maxillary expansion
Arm Title
group 2
Arm Type
Experimental
Arm Description
Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy
Arm Title
group 3
Arm Type
Experimental
Arm Description
Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy
Intervention Type
Procedure
Intervention Name(s)
Rapid maxillary expansion
Other Intervention Name(s)
maxillary expansion
Intervention Description
Device
Intervention Type
Procedure
Intervention Name(s)
Adenotonsillectomy
Intervention Description
Surgery
Primary Outcome Measure Information:
Title
Airway Volume
Description
cone beam computed tomography
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Quality of life before and after maxillary expansion:
Description
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).
Time Frame
1 and 7 months
Title
Pediatric Quality of Life
Description
Pediatric Quality of Life Inventory: 0-100 scale range. Higher scores indicate better HRQOL (Health-Related Quality of Life)
Time Frame
1 and 7 months
Title
Sleep Disturbance for Children
Description
Sleep Disturbance Scale for Children: scale range 26-130.Scores higher than 39 indicate sleep disturbance
Time Frame
1 and 7 months
Title
Nasal septum morphology
Description
Linear parameters by lateral tomographic distances
Time Frame
7 months
Title
Dental arch distances
Description
Dental arch growth as described by Mc Namara,2003
Time Frame
7 months
Title
Airway obstruction
Description
Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy
Time Frame
7 months
Title
Bruxism
Description
Bruxism episodes
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Valladares Neto, PHD
Organizational Affiliation
Universidade Federal de Goiás
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Odontologia
City
Goias
State/Province
Goiás
ZIP/Postal Code
74.605-220
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20848317
Citation
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.
Results Reference
background
PubMed Identifier
26763202
Citation
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.
Results Reference
background
PubMed Identifier
24231036
Citation
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.
Results Reference
background
PubMed Identifier
23561406
Citation
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.
Results Reference
background
PubMed Identifier
11468499
Citation
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.
Results Reference
background
PubMed Identifier
9065877
Citation
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.
Results Reference
background
PubMed Identifier
24474484
Citation
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.
Results Reference
background
Learn more about this trial
Maxillary Expansion Effects in Children With Upper Airway Obstruction
We'll reach out to this number within 24 hrs