Hyrax Vs. Invisalign Palatal Expander Clinical Study

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

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Key information

Conditions

Malocclusions Behavior Crowding Malocclusion Narrow Maxilla Narrow Maxillary Arch Spatial Behavior Stomatognathic Diseases Tooth Diseases

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orange Coast Orthodontics, Laguna Hills, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sherri Wilson-Lopes

CONTACT

[email protected]

Smita Sharma

CONTACT

[email protected]

408-470-4079

Sponsors and collaborators

Lead sponsor

Align Technology, Inc.

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Oct 28, 2024
Registry last updated: Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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