Hyrax Vs. Invisalign Palatal Expander Clinical Study

NCT06662279 · tracked via the Priya Life Science USA tracker

Sponsor

Align Technology, Inc.

Phase

Not applicable

Started

2024-10-25

Last updated

2024-12-04

Condition(s) studied

MalocclusionsNarrow MaxillaNarrow Maxillary ArchCrowding

Investigational drug(s) / intervention(s)

Removable Rapid Palatal ExpanderBanded Palatal Expander

Removable Rapid Palatal Expander: Removable palatal expander where expanders are changed to obtain up to .25mm expansion per expander

Banded Palatal Expander: Palatal expander cemented into mouth where a screw is turned to obtain .25mm expansion per turn

Study summary

The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.

Eligibility

Sex

ALL

Min age

6 Years

Max age

11 Years

Healthy volunteers

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

Primary outcome measure(s)

width of palate after expansion — from 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

Trial sites (4)

Facility	City	Region	Status
Orange Coast Orthodontics	Laguna Hills	California	Recruiting
Spillers Orthodontics	Warner Robins	Georgia	Recruiting
Innovative Orthodontic Centers	Naperville	Illinois	Recruiting
The Orthodontic Studio	Chevy Chase	Maryland	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06662279 on ClinicalTrials.gov ↗ ← All trials in the USA