Recruiting

3D-Printed & Laboratory-Fabricated

Sponsor:

Ildeu Andrade Jr.

Code:

NCT05743127

Conditions

Maxillary Expansion

Eligibility Criteria

Sex: All

Age: 8 - 13

Healthy Volunteers: Accepted

Interventions

3D-Printed Hyrax Expander

Conventional Laboratory Fabricated Hyrax Expander

Study Details

Brief 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.

Conditions

Maxillary Expansion

Study ID

NCT05743127

Start date

Feb 15, 2023

Status verified date

Mar, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 13

Healthy Volunteers: Accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group Conventional Expander

Conventional Laboratory Fabricated Hyrax Expander

experimental: Group 3-D Printed Expander

3D-Printed Hyrax Expander

Interventions

3D-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.

Conventional 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.

Primary outcome measure

  • Dimension of the Anterior Midpalatal Suture Opening [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Ildeu Andrade, DDS, MS, PhD

843-792-3366ildeu.andrade@pitt.edu

Locations

University of Pittsburgh - School of Dental Medicine

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Ildeu Andrade, DDS, MS, PhD

412-648-3369ildeu.andrade@pitt.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Ildeu Andrade, DDS, MS, PhD

8437923366andradei@musc.edu

More Information

Sponsor

Ildeu Andrade Jr.

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ildeu Andrade Jr. on 2026-03-20.