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

Primary Purpose

Overbite (Excessive) Horizontal

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Upper arch Wilson quadhelex appliance
Sponsored by
University of Alberta, Graduate Orthodontic Program
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overbite (Excessive) Horizontal

Eligibility Criteria

9 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Active upper Wilson appliance

    Non active upper expansion appliance

    Arm Description

    Active upper arch Wilson quadhelex appliance

    Non-Active upper arch Wilson quadhelex appliance

    Outcomes

    Primary Outcome Measures

    Lower jaw size
    Lower jaw size will be evaluated by computed tomography.
    Lower jaw projection
    Lower jaw projection will be evaluated by computed tomography.

    Secondary Outcome Measures

    Jaw joint size
    Jaw joint size will be evaluated by CBCT
    Base of skull bone size
    Base of skull bone size will be evaluated by CBCT
    Base of skull bone position
    Base of skull bone positions will be evaluated by CBCT
    Jaw joint position
    Jaw joint will be evaluated by CBCT

    Full Information

    First Posted
    April 12, 2015
    Last Updated
    September 13, 2017
    Sponsor
    University of Alberta, Graduate Orthodontic Program
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03286569
    Brief Title
    Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth
    Official Title
    Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2018 (Anticipated)
    Primary Completion Date
    February 1, 2020 (Anticipated)
    Study Completion Date
    February 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alberta, Graduate Orthodontic Program

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overbite (Excessive) Horizontal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active upper Wilson appliance
    Arm Type
    Active Comparator
    Arm Description
    Active upper arch Wilson quadhelex appliance
    Arm Title
    Non active upper expansion appliance
    Arm Type
    Placebo Comparator
    Arm Description
    Non-Active upper arch Wilson quadhelex appliance
    Intervention Type
    Device
    Intervention Name(s)
    Upper arch Wilson quadhelex appliance
    Intervention Description
    Upper arch Wilson quadhelex appliance
    Primary Outcome Measure Information:
    Title
    Lower jaw size
    Description
    Lower jaw size will be evaluated by computed tomography.
    Time Frame
    9 months
    Title
    Lower jaw projection
    Description
    Lower jaw projection will be evaluated by computed tomography.
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Jaw joint size
    Description
    Jaw joint size will be evaluated by CBCT
    Time Frame
    9 months
    Title
    Base of skull bone size
    Description
    Base of skull bone size will be evaluated by CBCT
    Time Frame
    9 months
    Title
    Base of skull bone position
    Description
    Base of skull bone positions will be evaluated by CBCT
    Time Frame
    9 months
    Title
    Jaw joint position
    Description
    Jaw joint will be evaluated by CBCT
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr. Tarek El-Bialy, PhD
    Phone
    780-492-2751
    Email
    telbialy@ualberta.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rabia Njie, BDS
    Phone
    780-850-8752
    Email
    rnjie@ualberta.ca

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19905846
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    21055598
    Citation
    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.
    Results Reference
    result

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

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