Hyrax Vs. Invisalign Palatal Expander Clinical Study

This study is comparing two types of devices used to widen the upper jaw (palate) in children: the Removable Rapid Palatal Expander (Invisalign Palatal Expander) and the Banded Palatal Expander (Hyrax expander). Researchers want to see which device works better and what the overall experience is like for patients. You might be able to join if you are 6 to 11 years old, need your upper jaw expanded, and have certain teeth already in your mouth. The main goal is to measure how much the palate widens after using the expander, which will be checked over about 4 months. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 36 participants. It compares two different devices for widening the palate.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your palate width will be measured from when you join the study until it finishes, which is expected to be about 4 months.

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NCT06662279

Hyrax Vs. Invisalign Palatal Expander Clinical Study

Recruiting
NAAges 6–11InterventionalTreatment
Align Technology, Inc.
~36 participants
Updated 2024-12-04 on ClinicalTrials.gov
What's tested:Removable Rapid Palatal ExpanderBanded Palatal Expander

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
width of palate after expansion
Measured over from enrollment to study completion, approximately 4 months
Malocclusions
Narrow Maxilla
Narrow Maxillary Arch
Crowding
4 sites across 4 states
California1
Georgia1
Illinois1
Maryland1

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Eligibility criteria

Inclusion

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

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
  • width of palate after expansionfrom 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