Clinical trial Recruiting at 2 sites Interventional Ages 8 to 13

Comparing 3D-Printed and Laboratory-Fabricated Maxillary Expanders

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

Run by University of Pittsburgh · NCT05743127 · Data updated 2026-11-12

This study is testing whether a 3D-printed maxillary expander is just as effective and more comfortable than a traditional one for kids aged 8-13 who need orthodontic treatment.

Quick facts

Study typeInterventional
Ages8 Years to 13 Years
SexAll
Enrollment42 (estimated)
SponsorUniversity of Pittsburgh
Academic / other
Locations2 sites (Pittsburgh, Pennsylvania and 1 other locations)
StatusRecruiting
StartedFebruary 15, 2023
Main results expectedDecember 31, 2026
Study endsMay 1, 2027
Registry record updatedMarch 20, 2026
Trial IDNCT05743127 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 8-13 years with maxillary transverse deficiency and whose parents are willing to consent to their participation.

Probably not a fit

Patients with previous orthodontic treatment or specific dental conditions such as temporomandibular disorders or craniofacial syndromes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness and comfort of two types of maxillary expanders used in orthodontics for children aged 8-13 years. One expander is traditionally made by hand in a laboratory, while the other is designed using computer software and produced with a 3D printer. Participants will be randomly assigned to receive either the laboratory-made or the 3D-printed expander, and their progress will be monitored through clinical follow-ups, including photos, x-rays, and dental scans over a period of six months. The goal is to determine if the 3D-printed expander is as effective as the conventional one while providing greater comfort to the patient.

Why it matters

Potential benefit: If successful, this study could lead to improved orthodontic treatment options that enhance patient comfort and effectiveness in maxillary expansion.

How similar studies have gone: While the use of 3D printing in orthodontics is gaining traction, this specific comparison of 3D-printed versus laboratory-fabricated expanders is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • University of Pittsburgh - School of Dental Medicine
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • Medical University of South Carolina
    Charleston, South Carolina, United States
    Recruiting

Study contacts

  • Principal investigator: Ildeu Andrade, DDS, MS, PhD — University of Pittsburgh
  • Study coordinator: Ildeu Andrade, DDS, MS, PhD
  • Email: ildeu.andrade@pitt.edu
  • Phone: 843-792-3366

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.