RECRUITING

3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-15
Study Completion:2024-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05743127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 13 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Maxillary anterior and/or posterior transverse deficiency with or without crossbite
  2. * Age of 8-13 years
  3. * Children whose parents/guardians are willing to consent to the child participating in the study
  4. * Children ages 12-13 who are willing to assent to participating in the study
  5. * Children who are orthodontic patients at the Medical University of South Carolina Department of Orthodontics
  6. * Subjects and parents/guardians who have access to an electronic device with internet connection
  1. * Patients with previous or ongoing orthodontic treatment
  2. * Patients whose parents have a strong preference as to which expander is used
  3. * Patients with a history of temporomandibular disorders
  4. * Presence of congenitally missing teeth
  5. * Traumatic loss of maxillary incisors
  6. * Patients with craniofacial syndromes, or cleft lip and/or palate

Contacts and Locations

Study Contact

Ildeu Andrade, DDS, MS, PhD
CONTACT
843-792-3366
andradei@musc.edu

Principal Investigator

Ildeu Andrade, DDS, MS, PhD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Ildeu Andrade, DDS, MS, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-15
Study Completion Date2024-08-01

Study Record Updates

Study Start Date2023-02-15
Study Completion Date2024-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Maxillary Expansion