Crowding, Malocclusions, Narrow Maxilla, Narrow Maxillary Arch
Conditions
Brief summary
The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.
Interventions
DEVICERemovable Rapid Palatal Expander
Removable palatal expander where expanders are changed to obtain up to .25mm expansion per expander
DEVICEBanded Palatal Expander
Palatal expander cemented into mouth where a screw is turned to obtain .25mm expansion per turn
Sponsors
Align Technology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Subject ages 6-11 years old * Subject must need maxillary expansion * Subjects must have erupted dentition in the area of the primary molars or permanent premolars and the first permanent molar
Exclusion criteria
* Subjects with palatal exostosis/surface aberration/ cleft palate * Subject's dentition not compatible with device or allergy to device materials * Subject with active caries, periodontal disease, TMD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| width of palate after expansion | from enrollment to study completion, approximately 4 months | intraoral scans will be taken of the subject's upper arch, including palate throughout the study and widths will be measured |
Countries
United States
Contacts
Primary ContactSmita Sharma
Backup ContactSherri Wilson-Lopes
Outcome results
None listed