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3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

NCT05743127 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-20

No results posted yet for this study

Summary

Maxillary expanders are orthodontic appliances that are commonly used to expand the upper jaw. The purpose of this study will be to compare the effects produced by two different maxillary expanders in children 8-13 years old. The first type of expander is made by hand in an orthodontic laboratory, and the second type of expander is designed on a computer and printed using 3D printers. Both expanders are already used in the MUSC Orthodontics Clinic. The purpose of this study is to see if the 3D printed expander is as effective as the traditional expander made by hand in the laboratory, with more comfort to the patient. Patients participating in the study will be randomly assigned to one of two groups: group A will be treated with a laboratory-made maxillary expander, and group B with a 3D-Printed maxillary expander. Information will be collected on the participants' standard clinical follow-up visits including photos, x-rays, and dental photo scans over the course of 6 months to see how the expander is working. In addition, as part of the research study, the participant will be asked to complete online questionnaires with assistance from parents or guardians about his/her quality of life and perception of possible pain and discomfort at different time points. The potential benefits of this study include the use of 3D technology to improve the quality of the orthodontic treatment, with more comfort to the patient.

Conditions

  • Maxillary Expansion

Interventions

DEVICE

3D-Printed Hyrax Expander

This is a type of maxillary expander that is designed on a computer and printed in metal using 3D printers and is used to expand the upper jaw.

DEVICE

Conventional Laboratory Fabricated Hyrax Expander

This is a type of maxillary expander that is made by hand in an orthodontic laboratory and is used to expand the upper jaw.

Sponsors & Collaborators

  • American Association of Orthodontics Foundation

    collaborator UNKNOWN

  • Ildeu Andrade Jr.

    lead OTHER

Principal Investigators

  • Ildeu Andrade, DDS, MS, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2026-12-31
Completion
2027-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05743127 on ClinicalTrials.gov