Hyrax Vs. Invisalign Palatal Expander Clinical Study

Not Applicable

Recruiting

• Conditions: Malocclusions; Narrow Maxilla; Narrow Maxillary Arch; Crowding

• Registration Number: NCT06662279
• Lead Sponsor: Align Technology, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-22
• Study Start: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-11
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
width of palate after expansion	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

Trial Locations

Locations (4)

Innovative Orthodontic Centers; 🇺🇸 Naperville, Illinois, United States

The Orthodontic Studio; 🇺🇸 Chevy Chase, Maryland, United States

Orange Coast Orthodontics; 🇺🇸 Laguna Hills, California, United States

Spillers Orthodontics; 🇺🇸 Warner Robins, Georgia, United States