Comparing two types of palatal expanders for children
Hyrax Vs. Invisalign Palatal Expander Clinical Study
This study is testing whether a new type of palatal expander called Invisalign works better and is more comfortable for kids aged 6 to 11 than the traditional Hyrax expander.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | Align Technology, Inc. Industry-sponsored |
| Locations | 4 sites (Laguna Hills, California and 3 other locations) |
| Trial ID | NCT06662279 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness and patient experience of the Invisalign Palatal Expander against the traditional Hyrax expander in children aged 6 to 11 years who require maxillary expansion. Participants will be assessed based on their dental needs and the compatibility of their dentition with the devices. The study will involve the use of both removable and banded palatal expanders to determine which method yields better expansion results and overall satisfaction. The findings could help inform orthodontic practices regarding the best options for treating malocclusions and narrow maxillary arches in young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 11 years who require maxillary expansion and have the appropriate dental conditions.
Not a fit: Patients with palatal exostosis, cleft palate, or those whose dentition is not compatible with the devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective and comfortable palatal expansion methods for children, improving orthodontic treatment outcomes.
How similar studies have performed: While there may be existing studies on palatal expanders, this specific comparison between Invisalign and Hyrax expanders is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Laguna Hills, California and 3 other locations
- Orange Coast Orthodontics — Laguna Hills, California, United States (Recruiting)
- Spillers Orthodontics — Warner Robins, Georgia, United States (Recruiting)
- Innovative Orthodontic Centers — Naperville, Illinois, United States (Recruiting)
- The Orthodontic Studio — Chevy Chase, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Smita Sharma
- Email: skaushik@aligntech.com
- Phone: 408-470-4079
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.