Recruiting

Hyrax vs. Invisalign

Sponsor:

Align Technology, Inc.

Code:

NCT06662279

Conditions

Malocclusions

Narrow Maxilla

Narrow Maxillary Arch

Crowding

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

Interventions

Removable Rapid Palatal Expander

Banded Palatal Expander

Study Details

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.

Conditions

Malocclusions

Narrow Maxilla

Narrow Maxillary Arch

Crowding

Study ID

NCT06662279

Start date

Oct 25, 2024

Status verified date

Oct, 2024

Completion date

Jan, 2026

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Invisalign Palatal Expander

active comparator: Hyrax Expander

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Smita Sharma

408-470-4079skaushik@aligntech.com

Sherri Wilson-Lopes

swilson@aligntech.com

Locations

Orange Coast Orthodontics

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Dr. Bobby Ghandehari, DDS

949-305-0550drbobby@orangecoastortho.com

Spillers Orthodontics

Recruiting

Warner Robins, Georgia, United States, 31088

Contacts

Dr. Don Spillers, DDS

478-953-2700don@drspillers.com

Innovative Orthodontic Centers

Recruiting

Naperville, Illinois, United States, 60540

Contacts

Dr. Manal Ibrahim, DDS

630-848-6960dribrahim@innovativeorthodonticconsultants.com

The Orthodontic Studio

Recruiting

Chevy Chase, Maryland, United States, 20815

Contacts

Dr. Jennifer Smith, DDS

301-307-5115drsmith@theorthostudiomd.com

More Information

Sponsor

Align Technology, Inc.

Last update posted

Dec 4, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Align Technology, Inc. on 2024-12-04.