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Clinical Trials/NCT03286569
NCT03286569RecruitingNot Applicable

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

University of Alberta1 site in 1 country60 target enrollmentStarted: April 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Lower jaw projection

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
9 Years to 11 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.)

Arms & Interventions

Active upper Wilson appliance

Active Comparator

Active upper arch Wilson quadhelex appliance

Intervention: Upper arch Wilson quadhelex appliance (Device)

Non active upper expansion appliance

Placebo Comparator

Non-Active upper arch Wilson quadhelex appliance

Intervention: Upper arch Wilson quadhelex appliance (Device)

Outcomes

Primary Outcomes

Lower jaw projection

Time Frame: 9 months

Lower jaw projection will be evaluated by computed tomography.

Lower jaw size

Time Frame: 9 months

Lower jaw size will be evaluated by computed tomography.

Secondary Outcomes

  • Base of skull bone position(9 months)
  • Jaw joint size(9 months)
  • Jaw joint position(9 months)
  • Base of skull bone size(9 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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