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

NCT03286569 — Not applicable, Recruiting, 60 participants, University of Alberta

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Registry	NCT03286569
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: double, treatment
Enrollment	60 (Estimated)
Sponsor	University of Alberta (Other)
Conditions	Overbite (Excessive) Horizontal
Interventions	Upper arch Wilson quadhelex appliance (Device)
Dates	start 2019-04-01, primary completion 2027-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2017-09-18, last updated 2026-01-07
Locations	1 site in Canada

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Active upper Wilson appliance	Active comparator	Device: Upper arch Wilson quadhelex appliance	Active upper arch Wilson quadhelex appliance
Non active upper expansion appliance	Placebo comparator	Device: Upper arch Wilson quadhelex appliance	Non-Active upper arch Wilson quadhelex appliance

Upper arch Wilson quadhelex appliance (Device): Upper arch Wilson quadhelex appliance

+Outcome measures

Primary outcomes

Lower jaw size [9 months]: Lower jaw size will be evaluated by computed tomography.
Lower jaw projection [9 months]: Lower jaw projection will be evaluated by computed tomography.

Secondary outcomes

Jaw joint size [9 months]: Jaw joint size will be evaluated by CBCT
Base of skull bone size [9 months]: Base of skull bone size will be evaluated by CBCT
Base of skull bone position [9 months]: Base of skull bone positions will be evaluated by CBCT
Jaw joint position [9 months]: Jaw joint will be evaluated by CBCT

+Eligibility

Sex: All, ages: 9 Years to 11 Years, accepts 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.)

+Locations (1)

Facility	City	Country	Status
University of Alberta	Edmonton, Alberta	Canada	Recruiting

+Publications

Results publication: 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
Results publication: 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

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