3D-Printed Versus Laboratory-Fabricated Hyrax Expanders
1 other identifier
interventional
42
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2023
CompletedStudy Start
First participant enrolled
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
February 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
March 20, 2026
March 1, 2026
3.9 years
January 10, 2023
March 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Dimension of the Anterior Midpalatal Suture Opening
The dimension of the anterior midpalatal suture opening between the maxillary halves will be measured digitally in millimeters on the occlusal radiograph using a calibrated ruler.
2 weeks
Secondary Outcomes (6)
Change in Interincisal Diastema Width
2 weeks
Change in Maxillary Molar Inclination
2 weeks
Change in Maxillary Arch Widths
2 weeks
Pain Perception assessed by Visual Analog Scale
2 weeks
Pain Perception assessed by Wong-Baker FACES Scale
2 weeks
- +1 more secondary outcomes
Study Arms (2)
Group Conventional Expander
EXPERIMENTALConventional Laboratory Fabricated Hyrax Expander
Group 3-D Printed Expander
EXPERIMENTAL3D-Printed Hyrax Expander
Interventions
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.
This is a type of maxillary expander that is made by hand in an orthodontic laboratory and is used to expand the upper jaw.
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ildeu Andrade Jr.lead
- American Association of Orthodontics Foundationcollaborator
Study Sites (2)
University of Pittsburgh - School of Dental Medicine
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ildeu Andrade, DDS, MS, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 10, 2023
First Posted
February 24, 2023
Study Start
February 15, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share