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Recruiting

NCT Number: NCT03286569

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

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.

Recruiting

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Key information

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location status: Recruiting

Location contact

Tarek El-Bialy

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Upper arch Wilson quadhelex appliance

Device

Upper arch Wilson quadhelex appliance

Primary outcomes

  1. Lower jaw size

    Time frame: 9 months

    Lower jaw size will be evaluated by computed tomography.

  2. Lower jaw projection

    Time frame: 9 months

    Lower jaw projection will be evaluated by computed tomography.

Secondary outcomes

  1. Jaw joint size

    Time frame: 9 months

    Jaw joint size will be evaluated by CBCT

  2. Base of skull bone size

    Time frame: 9 months

    Base of skull bone size will be evaluated by CBCT

  3. Base of skull bone position

    Time frame: 9 months

    Base of skull bone positions will be evaluated by CBCT

  4. Jaw joint position

    Time frame: 9 months

    Jaw joint will be evaluated by CBCT

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Tarek El-Bialy, PhD

CONTACT

[email protected]

780-492-2751

Rabia Njie, BDS

CONTACT

[email protected]

780-850-8752

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2017
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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