Recruiting

Orthodontics & Airway

Sponsor:

University of Alberta

Code:

NCT04190953

Conditions

Apnea

Airway Obstruction, Nasal

Mandible Small

Maxillary Hypoplasia

Eligibility Criteria

Sex: All

Age: 8 - 14

Healthy Volunteers: Accepted

Interventions

Twin block then Hyrax

Hyrax then Twin block

Study Details

Brief summary:

Breathing is a crucial function for everyone. Breathing impairment in children could lead to behavioral and cognitive problems at least. But what if orthodontic treatment could help those patients to breathe better, with less effort? This research proposal aims to find out if the increase in the upper airway volume seen in some research results can be related to a decrease in respiratory effort and an improvement in the breathing capacity of those patients. In other words, if a tube shape is changed or if a tube is enlarged, would the airflow passing inside the tube change in velocity? Or would there be more air? Therefore, investigating the pressure/airflow, volume/lumen relation and its possible changes after mandibular repositioning and maxillary expansion in children will lead to a better understanding of how orthodontics could potentially affect the upper airway. Previous studies have reported a link between mandibular advancement appliances and maxillary appliances to an increase in the upper airway volume. However, more studies are needed to evaluate the relationship between the changes in the upper airway volume and actual airflow and respiratory capability. The airway volume measurement is important to, preliminary, state if there is an increase in the upper airway after orthodontic treatment.

However a change in shape, even with the same volume, can affect the pressure and airflow. In this sense, the pressure drop analysis will allow an answer to those questions

Conditions

Apnea

Airway Obstruction, Nasal

Mandible Small

Maxillary Hypoplasia

Study ID

NCT04190953

Start date

Feb 18, 2020

Status verified date

Mar, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 14

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Twin Block then Hyrax

Patients will undergo mandibular advancement prior to maxillary expansion using Twin block prior to Hyrax

experimental: Hyrax then Twin block

Patients will undergo maxillary expansion prior to mandibular advancement using Hyrax prior to Twin block

no intervention: Control

Patients will wait 1,5 years before the start of treatment

Interventions

Twin block then Hyrax

Patients will undergo mandibular advancement prior to maxillary expansion

Hyrax then Twin block

Patients will undergo maxillary expansion prior to mandibular advancement

Primary outcome measure

  • Airflow [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Manuel Lagravere, PHD

7804927696manuel@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2R3

Contacts

SILVIA GIANONI-CAPENAKAS

5875949947capenaka@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-03-18.