Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth

January 5, 2026 updated by: University of Alberta
Young children with backward positioned lower jaw/chin will be recruited to have an upper jaw expansion appliance. Previous research showed that the use of similar appliances can lead to lower jaw forward growth. 60 young children aged 9-11 will be recruited to have either active or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the treatment. After participation, routine orthodontic treatment will be continued.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Previous research showed that the use of upper jaw expansion appliances can lead to lower jaw forward growth (1). 60 young children aged 9-11 with backward positioned lower jaw/chin will be recruited to have either active or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the treatment. After participation, routine orthodontic treatment will be continued.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Class II skeletal due to lower jaw backward projection
  2. Class II malocclusion
  3. Early mixed dentition (all first permanent molars erupted, as well as all erupting upper and lower permanent incisors)

Exclusion Criteria:

  1. Other orthodontic treatment provided
  2. Growth problems (craniofacial syndromes, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active upper Wilson appliance
Active upper arch Wilson quadhelex appliance
Device: Upper arch Wilson quadhelex appliance
Upper arch Wilson quadhelex appliance
Placebo Comparator: Non active upper expansion appliance
Non-Active upper arch Wilson quadhelex appliance
Device: Upper arch Wilson quadhelex appliance
Upper arch Wilson quadhelex appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower jaw size
Time Frame: 9 months
Lower jaw size will be evaluated by computed tomography.
9 months
Lower jaw projection
Time Frame: 9 months
Lower jaw projection will be evaluated by computed tomography.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jaw joint size
Time Frame: 9 months
Jaw joint size will be evaluated by CBCT
9 months
Base of skull bone size
Time Frame: 9 months
Base of skull bone size will be evaluated by CBCT
9 months
Base of skull bone position
Time Frame: 9 months
Base of skull bone positions will be evaluated by CBCT
9 months
Jaw joint position
Time Frame: 9 months
Jaw joint will be evaluated by CBCT
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 12, 2015

First Submitted That Met QC Criteria

September 13, 2017

First Posted (Actual)

September 18, 2017

Study Record Updates

Last Update Posted (Estimated)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00001731

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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