Actively Recruiting
3D-Printed Versus Laboratory-Fabricated Hyrax Expanders A Randomized Controlled Clinical Trial
Led by Ildeu Andrade Jr. · Updated on 2026-03-20
42
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
Sponsors
I
Ildeu Andrade Jr.
Lead Sponsor
A
American Association of Orthodontics Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two types of maxillary expanders used to widen the upper jaw in children aged 8 to 13 years with maxillary transverse deficiency. This trial compares a traditional expander made by hand in a laboratory to a newer expander designed on a computer and produced with 3D printing technology. The goal is to determine if the 3D-printed expander is as effective as the conventional one while potentially offering greater comfort to the patient. Participants will be randomly assigned to two groups: one group receives the conventional laboratory-made Hyrax expander, and the other group receives the 3D-printed Hyrax expander. Both devices are used in the orthodontic clinic to treat upper jaw expansion. The treatment period includes follow-up visits over six months where dental photos, X-rays, and scans are taken to monitor progress. Patients and their parents or guardians will also complete online questionnaires about quality of life and pain experienced at various times during the study. During the study, participants will attend regular clinical visits for standard orthodontic follow-up, including photos, X-rays, and dental scans to assess the expander's effects. Researchers will measure changes in the midpalatal suture opening, interincisal diastema width, molar inclination, and maxillary arch widths after two weeks. Pain perception and oral health-related quality of life will also be evaluated using specific pain scales and questionnaires. This study lasts six months, with ongoing monitoring of treatment progress and patient comfort.
CONDITIONS
Brief Title
3D-Printed Versus Laboratory-Fabricated Hyrax Expanders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive either a 3D-Printed Hyrax Expander or a Conventional Laboratory Fabricated Hyrax Expander to expand the upper jaw.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 2 locations
1
University of Pittsburgh - School of Dental Medicine
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
I
Ildeu Andrade, DDS, MS, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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