3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

Maxillary Expansion Clinical Trial

Official title:

3D-Printed Versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743127
• Other study ID #: 00115646
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: Ildeu Andrade, DDS, MS, PhD
• Phone: 843-792-3366
• Email: andradei[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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
• 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

Related Conditions & MeSH terms

• Maxillary Expansion

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	American Association of Orthodontics Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	Pain Perception assessed by Wong-Baker FACES Scale	Using an online questionnaire, patients will be asked about the highest pain level they will have experienced at different time points using the Wong-Baker FACES Scale. The more upset the face in the Wong-Baker FACES Scale, the more severe the pain.	2 weeks
Secondary	Oral Health Related Quality of Life (functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap) assessed by OHIP-14	Using an online questionnaire, patients will be asked about his/her quality of life at different time points using the short version of the Oral Health Impact Profile (OHIP-14). The OHIP-14 has 14 questions distributed across seven domains: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap. The scores for each domain and the total score will be evaluated. A higher score indicates a more negative perception of the individual with respect his/her quality of life. The lowest score is 0, which indicates a more positive perception of the individual with respect his/her quality of life. The highest score is 4, which indicates a more negative perception of the individual with respect his/her quality of life.	2 weeks