3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

Conditions

• Maxillary Expansion

Eligibility Criteria

Sex

ALL

Age

8 Years - 13 Years

Healthy Volunteers

Accepted

Interventions

• 3D-Printed Hyrax Expander — DEVICE
  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.
• Conventional Laboratory Fabricated Hyrax Expander — DEVICE
  This is a type of maxillary expander that is made by hand in an orthodontic laboratory and is used to expand the upper jaw.

Study Details

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.

Key Dates

Start date

Feb 15, 2023

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

May 1, 2027

Study Design

Enrollment

42 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group Conventional Expander
  Conventional Laboratory Fabricated Hyrax Expander
• Experimental: Group 3-D Printed Expander
  3D-Printed Hyrax Expander

Primary Outcome Measure

Dimension of the Anterior Midpalatal Suture Opening [ Time Frame: 2 weeks ]

Central Contacts

• Ildeu Andrade, DDS, MS, PhD
  843-792-3366
  [email protected]

Locations (2)

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