Comparing 3D-Printed and Laboratory-Fabricated Maxillary Expanders
3D-Printed Versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial
NA · University of Pittsburgh · NCT05743127
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 8 Years to 13 Years |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 2 sites (Pittsburgh, Pennsylvania and 1 other locations) |
| Trial ID | NCT05743127 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pittsburgh, Pennsylvania and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Maxillary Expansion