Hyrax Vs. Invisalign Palatal Expander Clinical Study
1 other identifier
interventional
36
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2024
CompletedStudy Start
First participant enrolled
October 25, 2024
CompletedFirst Posted
Study publicly available on registry
October 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedDecember 4, 2024
October 1, 2024
1 year
October 22, 2024
December 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
width of palate after expansion
intraoral scans will be taken of the subject's upper arch, including palate throughout the study and widths will be measured
from enrollment to study completion, approximately 4 months
Study Arms (2)
Invisalign Palatal Expander
ACTIVE COMPARATORHyrax Expander
ACTIVE COMPARATORInterventions
Removable palatal expander where expanders are changed to obtain up to .25mm expansion per expander
Palatal expander cemented into mouth where a screw is turned to obtain .25mm expansion per turn
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Orange Coast Orthodontics
Laguna Hills, California, 92653, United States
Spillers Orthodontics
Warner Robins, Georgia, 31088, United States
Innovative Orthodontic Centers
Naperville, Illinois, 60540, United States
The Orthodontic Studio
Chevy Chase, Maryland, 20815, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2024
First Posted
October 28, 2024
Study Start
October 25, 2024
Primary Completion
November 1, 2025
Study Completion
January 1, 2026
Last Updated
December 4, 2024
Record last verified: 2024-10