Hyrax Vs. Invisalign Palatal Expander Clinical Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorAlign Technology, Inc.
About this trial
The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Removable Rapid Palatal Expander
DeviceRemovable palatal expander where expanders are changed to obtain up to .25mm expansion per expander
Banded Palatal Expander
DevicePalatal expander cemented into mouth where a screw is turned to obtain .25mm expansion per turn
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Invisalign Palatal ExpanderActive comparator 1 intervention
Group B: Hyrax ExpanderActive comparator 1 intervention
Trial outcomes
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
Time frame
from enrollment to study completion, approximately 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov