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Recruiting NCT03286569

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

No phase Interventional Overbite (Excessive) Horizontal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Upper arch Wilson quadhelex appliance.
Who it may be relevant to
Registry conditions: Overbite (Excessive) Horizontal. Basic parameters: 9 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Upper arch Wilson quadhelex appliance
    Upper arch Wilson quadhelex appliance

Primary outcome measures

  • Lower jaw size [Time frame: 9 months]
  • Lower jaw projection [Time frame: 9 months]
Secondary outcome measures (4)
  • 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]

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • University of Alberta — Edmonton

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. PMID 19905846
  • 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. PMID 21055598

Identifiers

NCT: NCT03286569 · Pro00001731

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗