AzTrials
AzTrials

Airway ObstructionNCT03004300

Maxillary Expansion Effects in Children With Upper Airway Obstruction

A study testing Rapid maxillary expansion and Adenotonsillectomy in people with Airway Obstruction, run by Universidade Federal de Goias at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 5 to 9 yearsHealthy volunteers can take part
Conditions the study is for
Airway Obstruction
What is being tested?
Rapid maxillary expansion and Adenotonsillectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
13 Jul 2017to 31 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Faculdade de Odontologia

    Goiás, Goiás, 74.605-220

Other trials in Brazil

About this study

Official title: 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.

Being tested
Rapid maxillary expansion, Adenotonsillectomy
Keywords
maxillary expansion, adenotonsillar hypertrophy, airway volume
Medical subject headings
Airway Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rapid maxillary expansionProcedure or surgery

    Also called maxillary expansion

    Device

  • AdenotonsillectomyProcedure or surgery

    Surgery

Study groups in NCT03004300
Study groupRoleWhat they receive
group 1Active comparatorPatients with atresic maxilla without upper airway obstruction submitted to rapid maxillary expansion
Receives: Procedure: Rapid maxillary expansion
group 2ExperimentalPatients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy
Receives: Procedure: Rapid maxillary expansion; Procedure: Adenotonsillectomy
group 3ExperimentalPatients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy
Receives: Procedure: Rapid maxillary expansion; Procedure: Adenotonsillectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Airway Volume

    cone beam computed tomography

    Measured: 7 months

Secondary outcomes (7)

  1. 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).

    Measured: 1 and 7 months

  2. Pediatric Quality of Life

    Pediatric Quality of Life Inventory: 0-100 scale range. Higher scores indicate better HRQOL (Health-Related Quality of Life)

    Measured: 1 and 7 months

  3. Sleep Disturbance for Children

    Sleep Disturbance Scale for Children: scale range 26-130.Scores higher than 39 indicate sleep disturbance

    Measured: 1 and 7 months

  4. Nasal septum morphology

    Linear parameters by lateral tomographic distances

    Measured: 7 months

  5. Dental arch distances

    Dental arch growth as described by Mc Namara,2003

    Measured: 7 months

  6. Airway obstruction

    Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy

    Measured: 7 months

  7. Bruxism

    Bruxism episodes

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2016 (estimated)
  2. Study start13 Jul 2017
  3. Primary completion30 Mar 2019
  4. Study completion31 Mar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03004300
Sponsor's protocol ID
044029
Status last verified
Oct 2019
First submitted
22 Dec 2016
Last updated
16 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20848317

  • 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.

    PubMed 26763202

  • 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.

    PubMed 24231036

  • 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.

    PubMed 23561406

  • 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.

    PubMed 11468499

  • 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.

    PubMed 9065877

  • 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.

    PubMed 24474484

Questions about this trial

What is this clinical trial studying?

A study testing Rapid maxillary expansion and Adenotonsillectomy in people with Airway Obstruction, run by Universidade Federal de Goias at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Airway Volume (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03004300, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in