Clinical trial NCT05743127: 3D-Printed Versus Laboratory-Fabricated Hyrax Expanders
Official title: 3D-Printed Versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maxillary Expansion
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Association of Orthodontics Foundation
First posted: 2023-02-24
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Dimension of the Anterior Midpalatal Suture Opening
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in Interincisal Diastema Width
timeFrame: 2 weeks
measure: Change in Maxillary Molar Inclination
timeFrame: 2 weeks
measure: Change in Maxillary Arch Widths
timeFrame: 2 weeks
measure: Pain Perception assessed by Visual Analog Scale
timeFrame: 2 weeks
measure: Pain Perception assessed by Wong-Baker FACES Scale
timeFrame: 2 weeks
measure: Oral Health Related Quality of Life (functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap) assessed by OHIP-14
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh - School of Dental Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: University of Pittsburgh
name: Ildeu Andrade, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: