Hyrax Vs. Invisalign Palatal Expander Clinical Study

Part of paid clinical trials in Laguna Hills, California.

Sponsor
Align Technology, Inc.
Study ID
NCT06662279
Status
Recruiting

Conditions

  • Crowding
  • Malocclusions
  • Narrow Maxilla
  • Narrow Maxillary Arch

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Removable Rapid Palatal Expander — DEVICE
    Removable palatal expander where expanders are changed to obtain up to .25mm expansion per expander
  • Banded Palatal Expander — DEVICE
    Palatal expander cemented into mouth where a screw is turned to obtain .25mm expansion per turn

Study Details

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

Key Dates

Start date
Oct 25, 2024
Status verified
Oct 2024
Primary completion
Nov 30, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Invisalign Palatal Expander
  • Active Comparator: Hyrax Expander

Primary Outcome Measure

width of palate after expansion [ Time Frame: from enrollment to study completion, approximately 4 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Orange Coast OrthodonticsLaguna HillsCalifornia92653
Dr. Bobby Ghandehari, DDS
949-305-0550
Spillers OrthodonticsWarner RobinsGeorgia31088
Dr. Don Spillers, DDS
478-953-2700
Innovative Orthodontic CentersNapervilleIllinois60540
Dr. Manal Ibrahim, DDS
630-848-6960
The Orthodontic StudioChevy ChaseMaryland20815
Dr. Jennifer Smith, DDS
301-307-5115

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