3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

Ildeu Andrade Jr.

Status: Enrolling

Conditions: Maxillary Expansion

Treatments: Device: 3D-Printed Hyrax Expander; Device: Conventional Laboratory Fabricated Hyrax Expander

Study type: Interventional

Funder types: Other

Identifiers

NCT05743127

STUDY24070148

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Maxillary anterior and/or posterior transverse deficiency with or without crossbite
• Age of 8-13 years
• Children whose parents/guardians are willing to consent to the child participating in the study
• Children ages 12-13 who are willing to assent to participating in the study
• Children who are orthodontic patients at the Medical University of South Carolina Department of Orthodontics or University of Pittsburgh School of Dental Medicine
• Subjects and parents/guardians who have access to an electronic device with internet connection

Exclusion criteria

• Patients with previous or ongoing orthodontic treatment
• Patients whose parents have a strong preference as to which expander is used
• Patients with a history of temporomandibular disorders
• Presence of congenitally missing teeth
• Traumatic loss of maxillary incisors
• Patients with craniofacial syndromes, or cleft lip and/or palate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Group Conventional Expander

Experimental group

Description:

Conventional Laboratory Fabricated Hyrax Expander

Treatment:

Device: Conventional Laboratory Fabricated Hyrax Expander

Group 3-D Printed Expander

Experimental group

Description:

3D-Printed Hyrax Expander

Treatment:

Device: 3D-Printed Hyrax Expander