Hyrax Vs. Invisalign Palatal Expander Clinical Study

Align Technology

Status: Enrolling

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

Treatments: Device: Banded Palatal Expander; Device: Removable Rapid Palatal Expander

Study type: Interventional

Funder types: Industry

Identifiers

NCT06662279

A025375

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Invisalign Palatal Expander

Active Comparator group

Treatment:

Device: Removable Rapid Palatal Expander

Hyrax Expander

Active Comparator group

Treatment:

Device: Banded Palatal Expander