Actively Recruiting
Hyrax Vs. Invisalign Palatal Expander Clinical Study
Led by Align Technology, Inc. · Updated on 2024-12-04
36
Participants Needed
4
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Hyrax Vs. Invisalign Palatal Expander Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 4 months
Participants receive a palatal expander device to aid in maxillary expansion.
Trial Site Locations
Total: 4 locations
1
Orange Coast Orthodontics
Laguna Hills, California, United States, 92653
Actively Recruiting
2
Spillers Orthodontics
Warner Robins, Georgia, United States, 31088
Actively Recruiting
3
Innovative Orthodontic Centers
Naperville, Illinois, United States, 60540
Actively Recruiting
4
The Orthodontic Studio
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
Research Team
S
Smita Sharma
S
Sherri Wilson-Lopes
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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