3D-Printed Versus Laboratory-Fabricated Hyrax Expanders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D-Printed Hyrax Expander, Conventional Laboratory Fabricated Hyrax Expander.
- Who it may be relevant to
- Registry conditions: Maxillary Expansion. Basic parameters: 8 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
3D-Printed Versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Device 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. - Device 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 measures
- Dimension of the Anterior Midpalatal Suture Opening [Time frame: 2 weeks]
Secondary outcome measures (6)
- Change in Interincisal Diastema Width [Time frame: 2 weeks]
- Change in Maxillary Molar Inclination [Time frame: 2 weeks]
- Change in Maxillary Arch Widths [Time frame: 2 weeks]
- Pain Perception assessed by Visual Analog Scale [Time frame: 2 weeks]
- Pain Perception assessed by Wong-Baker FACES Scale [Time frame: 2 weeks]
- Oral Health Related Quality of Life (functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap) assessed by OHIP-14 [Time frame: 2 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Pittsburgh - School of Dental Medicine — Pittsburgh
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT05743127 · STUDY24070148