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Not Yet Recruiting NCT05743127

3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

Conditions: Maxillary Expansion

Sex: All
Ages: 8 Years – 13 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 42
Sponsor: Medical University of South Carolina

Location: United States

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 Criteria

Inclusion Criteria:Maxillary anterior and/or posterior transverse deficiency with or without crossbiteAge of 8-13 yearsChildren whose parents/guardians are willing to consent to the child participating in the studyChildren ages 12-13 who are willing to assent to participating in the studyChildren who are orthodontic patients at the Medical University of South Carolina Department of OrthodonticsSubjects and parents/guardians who have access to an electronic device with internet connectionExclusion Criteria:Patients with previous or ongoing orthodontic treatmentPatients whose parents have a strong preference as to which expander is usedPatients with a history of temporomandibular disordersPresence of congenitally missing teethTraumatic loss of maxillary incisorsPatients with craniofacial syndromes, or cleft lip and/or palate

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05743127). StuddyBuddy aggregates publicly available trial information.