Study Comparing Invisalign and Hyrax Palatal Expanders for Children Aged 6 to 11 Needing Maxillary Expansion

What this Trial Is About

Researchers are comparing two devices used to widen the upper jaw in children aged 6 to 11 years who need maxillary expansion due to conditions such as malocclusions, narrow maxilla, narrow maxillary arch, or crowding. The study aims to evaluate the amount of palate expansion achieved and the overall experience of using the Invisalign Palatal Expander versus the Hyrax expander. Participants will be randomly assigned to use either the Invisalign Palatal Expander, a removable device that is replaced to achieve up to 0.25 mm expansion per device, or the Hyrax Expander, a banded device fixed in the mouth where a screw is turned to obtain 0.25 mm expansion per turn. The study duration is approximately four months from enrollment to completion. During the study, participants will be monitored to measure the width of their palate after expansion. The study involves regular assessments to track changes in palate width and overall device experience. The total participation time is about four months, during which safety and effectiveness will be evaluated under medical supervision.

Hyrax Vs. Invisalign Palatal Expander Clinical Study