NCT03004300

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

July 13, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

December 22, 2016

Last Update Submit

October 14, 2019

Conditions

Airway Obstruction

Keywords

maxillary expansionadenotonsillar hypertrophyairway volume

Outcome Measures

Primary Outcomes (1)

  • Airway Volume

    cone beam computed tomography

    7 months

Secondary Outcomes (7)

  • Quality of life before and after maxillary expansion:

    1 and 7 months

  • Pediatric Quality of Life

    1 and 7 months

  • Sleep Disturbance for Children

    1 and 7 months

  • Nasal septum morphology

    7 months

  • Dental arch distances

    7 months

  • +2 more secondary outcomes

Study Arms (3)

group 1

ACTIVE COMPARATOR

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

Procedure: Rapid maxillary expansion

group 2

EXPERIMENTAL

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

Procedure: Rapid maxillary expansionProcedure: Adenotonsillectomy

group 3

EXPERIMENTAL

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

Procedure: Rapid maxillary expansionProcedure: Adenotonsillectomy

Interventions

Rapid maxillary expansionPROCEDURE

Device

Also known as: maxillary expansion
group 1group 2group 3
AdenotonsillectomyPROCEDURE

Surgery

group 2group 3

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Craniofacial syndromes or neurologic disease diagnosis.
  • History of adenotonsillectomy and orthodontic treatment
  • History of facial trauma
  • Morbid obesity
  • Premature loss of posterior teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Odontologia

Goiás, Goiás, 74.605-220, Brazil

Location

Related Publications (7)

  • 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.

    PMID: 20848317BACKGROUND

  • 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.

    PMID: 26763202BACKGROUND

  • 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.

    PMID: 24231036BACKGROUND

  • 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.

    PMID: 23561406BACKGROUND

  • 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.

    PMID: 11468499BACKGROUND

  • 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.

    PMID: 9065877BACKGROUND

  • 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.

    PMID: 24474484BACKGROUND

MeSH Terms

Conditions

Airway Obstruction

Interventions

Palatal Expansion Technique

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Orthodontics, CorrectiveOrthodonticsDentistry

Study Officials

  • Jose Valladares Neto, PHD

    Universidade Federal de Goiás

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD Professor

Study Record Dates

First Submitted

December 22, 2016

First Posted

December 28, 2016

Study Start

July 13, 2017

Primary Completion

March 30, 2019

Study Completion

March 31, 2020

Last Updated

October 16, 2019

Record last verified: 2019-10

Locations

BR(1)