Upper Airway's Pressure Drop Analyses After Mandibular Advancement and Maxillary Expansion

NCT04190953 | Recruiting

• 1 other identifier: Pro00095427
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Airflow

  Airflow of the upper airway using pressure drop experimental analyzed using the CBCTs scans to print out the models of the upper airway.

  3 years

Secondary Outcomes (2)

• Dental changes

  3 years

• Skeletal changes

  3 years

Study Arms (3)

Twin Block then Hyrax

EXPERIMENTAL

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

Other: Twin block then Hyrax

Hyrax then Twin block

EXPERIMENTAL

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

Other: Hyrax then Twin block

Control

NO INTERVENTION

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

Interventions

Twin block then Hyrax OTHER

Patients will undergo mandibular advancement prior to maxillary expansion

Twin Block then Hyrax

Hyrax then Twin block OTHER

Patients will undergo maxillary expansion prior to mandibular advancement

Hyrax then Twin block

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

MeSH Terms

Conditions

Apnea; Nasal Obstruction; Micrognathism; Retrognathia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Otorhinolaryngologic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mandibular Diseases

Study Officials

• Silvia G Capenakas, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Lagravere, PHD

CONTACT

7804927696; manuel@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: When data will be analyzed, data will be coded to keep confidentiality for time and type of treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Twin block and Hyrax appliances will be installed in 1/3 of the patients, while hyrax and twin block devices will be applied to the other 1/3 of the patients. Another 1/3 of patients will be the control group with no treatment

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 9, 2019
• Study Start: February 18, 2020
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)