Hyrax Vs. Invisalign Palatal Expander Clinical Study

NCT ID: NCT06662279

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-25

Study Completion Date

2026-01-31

Brief Summary

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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

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Conditions

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Malocclusions Narrow Maxilla Narrow Maxillary Arch Crowding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Invisalign Palatal Expander

Group Type ACTIVE_COMPARATOR

Removable Rapid Palatal Expander

Intervention Type DEVICE

Removable palatal expander where expanders are changed to obtain up to .25mm expansion per expander

Hyrax Expander

Group Type ACTIVE_COMPARATOR

Banded Palatal Expander

Intervention Type DEVICE

Palatal expander cemented into mouth where a screw is turned to obtain .25mm expansion per turn

Interventions

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Removable Rapid Palatal Expander

Removable palatal expander where expanders are changed to obtain up to .25mm expansion per expander

Intervention Type DEVICE

Banded Palatal Expander

Palatal expander cemented into mouth where a screw is turned to obtain .25mm expansion per turn

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Align Technology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orange Coast Orthodontics

Laguna Hills, California, United States

Site Status RECRUITING

Spillers Orthodontics

Warner Robins, Georgia, United States

Site Status RECRUITING

Innovative Orthodontic Centers

Naperville, Illinois, United States

Site Status RECRUITING

The Orthodontic Studio

Chevy Chase, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Smita Sharma

Role: CONTACT

408-470-4079

Sherri Wilson-Lopes

Role: CONTACT

Facility Contacts

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Dr. Bobby Ghandehari, DDS

Role: primary

949-305-0550

Dr. Don Spillers, DDS

Role: primary

478-953-2700

Dr. Manal Ibrahim, DDS

Role: primary

630-848-6960

Dr. Jennifer Smith, DDS

Role: primary

301-307-5115

Other Identifiers

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A025375

Identifier Type: -

Identifier Source: org_study_id