Hyrax Vs. Invisalign Palatal Expander Clinical Study

December 2, 2024 updated by: Align Technology, Inc.
The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Laguna Hills, California, United States, 92653
    • Georgia
      • Warner Robins, Georgia, United States, 31088
        • Recruiting
        • Spillers Orthodontics
        • Contact:
    • Illinois
    • Maryland
      • Chevy Chase, Maryland, United States, 20815

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Invisalign Palatal Expander
Device: Removable Rapid Palatal Expander
Removable palatal expander where expanders are changed to obtain up to .25mm expansion per expander
Active Comparator: Hyrax Expander
Device: Banded Palatal Expander
Palatal expander cemented into mouth where a screw is turned to obtain .25mm expansion per turn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
width of palate after expansion
Time Frame: 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
from enrollment to study completion, approximately 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Align Technology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A025375

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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