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

NCT ID: NCT03286569

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2027-02-01

Brief Summary

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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

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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

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Overbite (Excessive) Horizontal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active upper Wilson appliance

Active upper arch Wilson quadhelex appliance

Group Type ACTIVE_COMPARATOR

Upper arch Wilson quadhelex appliance

Intervention Type DEVICE

Upper arch Wilson quadhelex appliance

Non active upper expansion appliance

Non-Active upper arch Wilson quadhelex appliance

Group Type PLACEBO_COMPARATOR

Upper arch Wilson quadhelex appliance

Intervention Type DEVICE

Upper arch Wilson quadhelex appliance

Interventions

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Upper arch Wilson quadhelex appliance

Upper arch Wilson quadhelex appliance

Intervention Type DEVICE

Eligibility Criteria

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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.)
Minimum Eligible Age

9 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Dr. Tarek El-Bialy, PhD

Role: CONTACT

780-492-2751

Rabia Njie, BDS

Role: CONTACT

780-850-8752

Facility Contacts

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Tarek El-Bialy

Role: primary

References

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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.

Reference Type RESULT
PMID: 19905846 (View on PubMed)

Guest 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.

Reference Type RESULT
PMID: 21055598 (View on PubMed)

Other Identifiers

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Pro00001731

Identifier Type: -

Identifier Source: org_study_id

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