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Search / Trial NCT05743127

3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

Launched by ILDEU ANDRADE JR. · Feb 14, 2023

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two types of orthodontic expanders used to widen the upper jaw in children aged 8 to 13. One expander is made by hand in a lab, while the other is created using 3D printing technology. The goal is to find out if the 3D-printed expander works just as well as the traditional one and if it offers more comfort for the kids. Children in the study will be randomly assigned to receive either type of expander, and their progress will be monitored over six months through regular check-ups, including photos and x-rays. Parents will also help their children fill out online surveys about their comfort and quality of life during treatment.

To be eligible for this study, children must have a specific jaw condition and need to be orthodontic patients at the Medical University of South Carolina. Parents must agree to their child's participation, and children ages 12 and up should also be willing to participate. However, children who have had previous orthodontic treatment or certain dental issues, like jaw disorders or missing teeth, cannot take part in this study. Overall, this trial aims to improve orthodontic treatment using modern technology while ensuring a comfortable experience for young patients.

Gender

ALL

Eligibility criteria

  • 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

About Ildeu Andrade Jr.

Ildeu Andrade Jr. is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative clinical studies. With a focus on ethical practices and regulatory compliance, Ildeu Andrade Jr. collaborates with healthcare professionals and institutions to facilitate the development of new therapies and treatments. The organization prioritizes patient safety and data integrity while fostering a scientific environment that promotes rigorous investigation and collaboration in the pursuit of groundbreaking healthcare solutions.

Locations

Charleston, South Carolina, United States

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Ildeu Andrade, DDS, MS, PhD

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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