Clinical trial Recruiting at 1 site Interventional Ages 8 to 14

Improving breathing in children with orthodontic treatment

Official title: Skeletal, Dental and Upper Airway Changes in Skeletal Class II Division 1 Patients With the Constricted Maxilla (8-14 Years Old) Treated With Twin Block and Hyrax, Evaluated Through Pressure Drop Experimental Analysis.

Run by University of Alberta · NCT04190953 · Data updated 2026-11-12

This study is testing if certain orthodontic treatments can help children with breathing problems by improving their airway size and making it easier to breathe.

Quick facts

Study typeInterventional
Ages8 Years to 14 Years
SexAll
Enrollment90 (estimated)
SponsorUniversity of Alberta
Academic / other
Locations1 site (Edmonton, Alberta)
StatusRecruiting
StartedFebruary 18, 2020
Main results expectedMarch 1, 2027
Study endsMarch 1, 2027
Registry record updatedMarch 18, 2026
Trial IDNCT04190953 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 8-14 with skeletal class II division 1 malocclusion and maxillary constriction.

Probably not a fit

Patients with syndromic conditions, previous orthodontic treatment, or severe oral health issues may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research investigates how orthodontic treatments, specifically mandibular advancement and maxillary expansion, can enhance upper airway volume and reduce respiratory effort in children with class II malocclusion. The study will analyze changes in airway dimensions and airflow resistance using a randomized crossover controlled trial design involving 90 children aged 8-14. Participants will be divided into groups receiving different treatment sequences, and their respiratory capabilities will be assessed using portable polysomnography. The goal is to establish a correlation between orthodontic interventions and improved breathing outcomes.

Why it matters

Potential benefit: If successful, this study could lead to improved breathing and reduced respiratory issues in children undergoing orthodontic treatment.

How similar studies have gone: Previous studies have indicated a positive relationship between orthodontic interventions and airway improvements, suggesting this approach has potential based on existing evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* children between the ages 8-14 years old (8-12 years old girls and 9-14 years old boys), presenting skeletal class II division 1 malocclusion with maxillary constriction

Exclusion Criteria:

* syndromic patients, previous ortho history, non-compliance, severe oral health issues (cavities, poor oral hygiene)

Where it's running

  • University of Alberta
    Edmonton, Alberta, Canada
    Recruiting

Study contacts

  • Principal investigator: Silvia G Capenakas, MSc — University of Alberta
  • Study coordinator: Manuel Lagravere, PHD
  • Email: manuel@ualberta.ca
  • Phone: 7804927696

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.