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

Overbite (Excessive) Horizontal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03286569
• Other study ID #: Pro00001731
• Status: Not yet recruiting
• Phase: N/A
• First received: April 12, 2015
• Last updated: September 13, 2017
• Start date: April 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: September 2017
• Source: University of Alberta, Graduate Orthodontic Program
• Contact: Dr. Tarek El-Bialy, PhD
• Phone: 780-492-2751
• Email: telbialy[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Overbite (Excessive) Horizontal

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta, Graduate Orthodontic Program

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower jaw size	Lower jaw size will be evaluated by computed tomography.	9 months
Primary	Lower jaw projection	Lower jaw projection will be evaluated by computed tomography.	9 months
Secondary	Jaw joint size	Jaw joint size will be evaluated by CBCT	9 months
Secondary	Base of skull bone size	Base of skull bone size will be evaluated by CBCT	9 months
Secondary	Base of skull bone position	Base of skull bone positions will be evaluated by CBCT	9 months
Secondary	Jaw joint position	Jaw joint will be evaluated by CBCT	9 months