RecruitingNot ApplicableNCT05743127

3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

3D-Printed Versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial


Sponsor

Ildeu Andrade Jr.

Enrollment

42 participants

Start Date

Feb 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 13 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing 3D-printed dental palate expanders to traditionally made (laboratory-fabricated) ones in children who need orthodontic treatment to widen a narrow upper jaw. The goal is to see if 3D-printed expanders work just as well and feel just as comfortable. **You may be eligible if...** - You are between 8 and 13 years old - You have a narrow upper jaw with or without a crossbite - You are an orthodontic patient at the Medical University of South Carolina or University of Pittsburgh School of Dental Medicine - Your parent or guardian consents to participation (and you agree too if aged 12–13) - You have access to a device with internet access **You may NOT be eligible if...** - You have previously had or are currently undergoing orthodontic treatment - Your parent strongly prefers one specific type of expander - You have jaw joint (TMJ) problems - You are missing teeth from birth or from injury to your front teeth - You have a craniofacial syndrome or cleft lip/palate Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE3D-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.

DEVICEConventional 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.


Locations(2)

University of Pittsburgh - School of Dental Medicine

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT05743127


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