Overbite (Excessive) HorizontalNCT03286569
Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth
A study testing Upper arch Wilson quadhelex appliance in people with Overbite (Excessive) Horizontal, run by University of Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Overbite (Excessive) Horizontal
- What is being tested?
- Upper arch Wilson quadhelex appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Class II skeletal due to lower jaw backward projection
- Class II malocclusion
- Early mixed dentition (all first permanent molars erupted, as well as all erupting upper and lower permanent incisors)
Who cannot join
- Other orthodontic treatment provided
- Growth problems (craniofacial syndromes, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2R3
Tarek El-Bialy, telbialy@ualberta.ca
About this study
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.
Read the 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.
- Conditions
- Overbite (Excessive) Horizontal
- Being tested
- Upper arch Wilson quadhelex appliance
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper arch Wilson quadhelex applianceDevice
Upper arch Wilson quadhelex appliance
| Study group | Role | What they receive |
|---|---|---|
| Active upper Wilson appliance | Active comparator | Active upper arch Wilson quadhelex appliance Receives: Device: Upper arch Wilson quadhelex appliance |
| Non active upper expansion appliance | Placebo comparator | Non-Active upper arch Wilson quadhelex appliance Receives: Device: Upper arch Wilson quadhelex appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower jaw size
Lower jaw size will be evaluated by computed tomography.
Measured: 9 months
Lower jaw projection
Lower jaw projection will be evaluated by computed tomography.
Measured: 9 months
Secondary outcomes (4)
Jaw joint size
Jaw joint size will be evaluated by CBCT
Measured: 9 months
Base of skull bone size
Base of skull bone size will be evaluated by CBCT
Measured: 9 months
Base of skull bone position
Base of skull bone positions will be evaluated by CBCT
Measured: 9 months
Jaw joint position
Jaw joint will be evaluated by CBCT
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Apr 2019
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overbite (Excessive) HorizontalStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286569
- Sponsor's protocol ID
- Pro00001731
- Status last verified
- Jan 2026
- First submitted
- 12 Apr 2015
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
McNamara JA Jr, Sigler LM, Franchi L, Guest SS, Baccetti T. Changes in occlusal relationships in mixed dentition patients treated with rapid maxillary expansion. A prospective clinical study. Angle Orthod. 2010 Mar;80(2):230-8. doi: 10.2319/040309-192.1.
PubMed 19905846Guest SS, McNamara JA Jr, Baccetti T, Franchi L. Improving Class II malocclusion as a side-effect of rapid maxillary expansion: a prospective clinical study. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):582-91. doi: 10.1016/j.ajodo.2008.12.026.
PubMed 21055598
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth
- ClinicalTrials.gov ID
- NCT03286569
- Acronym / sponsor ID
- Pro00001731
- Conditions
- Overbite (Excessive) Horizontal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active upper Wilson appliance | Active comparator | Device: Upper arch Wilson quadhelex applianceActive upper arch Wilson quadhelex appliance |
| Non active upper expansion appliance | Placebo comparator | Device: Upper arch Wilson quadhelex applianceNon-Active upper arch Wilson quadhelex appliance |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Class II skeletal due to lower jaw backward projection
- Class II malocclusion
- Early mixed dentition (all first permanent molars erupted, as well as all erupting upper and lower permanent incisors)
Key exclusion criteria (2 listed)
- Other orthodontic treatment provided
- Growth problems (craniofacial syndromes, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper arch Wilson quadhelex applianceUpper arch Wilson quadhelex appliance | Device | Active upper Wilson appliance, Non active upper expansion appliance |
Primary outcome
Lower jaw size
Time frame: 9 months
Lower jaw size will be evaluated by computed tomography.
Lower jaw projection
Time frame: 9 months
Lower jaw projection will be evaluated by computed tomography.
4 secondary outcomes
Jaw joint size
Time frame: 9 months
Base of skull bone size
Time frame: 9 months
Base of skull bone position
Time frame: 9 months
Jaw joint position
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Results publication: PubMed 19905846McNamara JA Jr, Sigler LM, Franchi L, Guest SS, Baccetti T. Changes in occlusal relationships in mixed dentition patients treated with rapid maxillary expansion. A prospective clinical study. Angle Orthod. 2010 Mar;80(2):230-8. doi: 10.2319/040309-192.1.
- Results publication: PubMed 21055598Guest SS, McNamara JA Jr, Baccetti T, Franchi L. Improving Class II malocclusion as a side-effect of rapid maxillary expansion: a prospective clinical study. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):582-91. doi: 10.1016/j.ajodo.2008.12.026.
Related trials for Overbite (Excessive) Horizontal
Enrolling by invitationObservational study
Long-term Stability of Treatment With the Twin Block Appliance
Malocclusion, Angle Class II, Overbite (Excessive) Horizontal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper arch Wilson quadhelex appliance in people with Overbite (Excessive) Horizontal, run by University of Alberta at 1 site in Canada.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Tarek El-Bialy, PhD (780-492-2751, telbialy@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower jaw size (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT03286569, which also lists 2 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 7 Jan 2026.