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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 6 Years and 11 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Orange Coast Orthodontics
Laguna Hills, California 92653
Contact:
Dr. Bobby Ghandehari, DDS
949-305-0550
drbobby@orangecoastortho.com

Spillers Orthodontics
Warner Robins, Georgia 31088
Contact:
Dr. Don Spillers, DDS
478-953-2700
don@drspillers.com

Innovative Orthodontic Centers
Naperville, Illinois 60540
Contact:
Dr. Manal Ibrahim, DDS
630-848-6960
dribrahim@innovativeorthodonticconsultants.com

The Orthodontic Studio
Chevy Chase, Maryland 20815
Contact:
Dr. Jennifer Smith, DDS
301-307-5115
drsmith@theorthostudiomd.com

More Details

Status
Recruiting
Sponsor
Align Technology, Inc.

Study Contact

Smita Sharma
408-470-4079
skaushik@aligntech.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.