Health TrialsbyHealthPanel

3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

ConditionMaxillary Expansion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-13
SponsorIldeu Andrade Jr.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3D-Printed Hyrax Expander

    Device

    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.

  • Conventional Laboratory Fabricated Hyrax Expander

    Device

    This is a type of maxillary expander that is made by hand in an orthodontic laboratory and is used to expand the upper jaw.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Group Conventional ExpanderExperimental treatment 1 intervention
Group B: Group 3-D Printed ExpanderExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
2 weeks

Secondary outcomes

1

Change in Interincisal Diastema Width

The change in interincisal diastema width will be measured in millimeters on the post-expansion (T1) digital models between the maxillary central incisors using OrthoAnalyzer 3D software.

Time frame
2 weeks
2

Change in Maxillary Molar Inclination

Using measurement tools in OrthoAnalyzer 3D software and the T0 digital models, the inter-molar inclination of the maxillary permanent first molars will be evaluated. The inclination of the T1 maxillary permanent first molars will be measured in a like-manner as the T0 digital models. The intermolar inclination measurement at T1 will be subtracted from the intermolar inclination measurement at T0 to record any presumably positive increase in molar inclination.

Time frame
2 weeks
3

Change in Maxillary Arch Widths

The measurements of the maxillary dental arch widths will be performed on the pre-expansion (T0) and post-expansion (T1) digital models using the OrthoAnalyzer software. The intercanine, interpremolar or first deciduous molar, and intermolar widths will be measured in millimeters. The widths at T0 will be subtracted from the widths at T1 to record any positive increase in arch widths.

Time frame
2 weeks
4

Pain Perception assessed by Visual Analog Scale

Using an online questionnaire, patients will be asked about the highest pain level they will have experienced at different time points using the visual analog scale (VAS). The higher the value in the VAS scale, the more severe the pain.

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ildeu Andrade Jr.

Lead sponsor

University of Pittsburgh

Sponsor institution

American Association of Orthodontics Foundation

Collaborator

Source ClinicalTrials.gov
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