Recruiting NCT06662279
Hyrax Vs. Invisalign Palatal Expander Clinical Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Removable Rapid Palatal Expander, Banded Palatal Expander.
- Who it may be relevant to
- Registry conditions: Malocclusions, Narrow Maxilla, Narrow Maxillary Arch, Crowding. Basic parameters: 6 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.
Interventions
- Device Removable Rapid Palatal Expander
Removable palatal expander where expanders are changed to obtain up to .25mm expansion per expander - Device Banded Palatal Expander
Palatal expander cemented into mouth where a screw is turned to obtain .25mm expansion per turn
Primary outcome measures
- width of palate after expansion [Time frame: from enrollment to study completion, approximately 4 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Orange Coast Orthodontics — Laguna Hills
- Spillers Orthodontics — Warner Robins
- Innovative Orthodontic Centers — Naperville
- The Orthodontic Studio — Chevy Chase
Identifiers
NCT: NCT06662279 · A025375