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Orthodontic Appliance

3D-Printed vs Conventional Hyrax Expanders for Maxillary Expansion

N/A

Recruiting

Led By Ildeu Andrade, DDS, MS, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

Study Summary

This trial will compare two maxillary expanders used to widen the upper jaw in 8-13 year olds. One is made in a lab, the other with 3D printing. Data will be collected over 6 months to gauge effectiveness, comfort, and quality of life. Benefits include potential use of 3D tech to improve orthodontic care.

Who is the study for?

This trial is for children aged 8-13 who need upper jaw expansion and are patients at the MUSC Orthodontics Clinic. They must have internet access to complete questionnaires. It's not for those with a preference for expander type, history of jaw disorders, missing teeth, prior orthodontic treatment, traumatic tooth loss, or craniofacial syndromes.Check my eligibility

What is being tested?

The study compares two types of maxillary expanders: one hand-made in a lab and one made using 3D printing technology. Children will be randomly assigned to receive either the conventional or the 3D-printed expander to determine effectiveness and comfort over six months.See study design

What are the potential side effects?

While specific side effects aren't listed, potential discomforts may include pain from wearing the expanders and possible irritation inside the mouth. The online questionnaires will help assess any discomfort or changes in quality of life.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dimension of the Anterior Midpalatal Suture Opening

Secondary outcome measures

Change in Interincisal Diastema Width

Change in Maxillary Arch Widths

Change in Maxillary Molar Inclination

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group Conventional ExpanderExperimental Treatment1 Intervention

Conventional Laboratory Fabricated Hyrax Expander

Group II: Group 3-D Printed ExpanderExperimental Treatment1 Intervention

3D-Printed Hyrax Expander

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

American Association of Orthodontics FoundationUNKNOWN

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,594 Total Patients Enrolled

Ildeu Andrade, DDS, MS, PhDPrincipal InvestigatorMedical University of South Carolina

Media Library

3D-Printed Hyrax Expander (Orthodontic Appliance) Clinical Trial Eligibility Overview. Trial Name: NCT05743127 — N/A

Maxillary Expansion Research Study Groups: Group 3-D Printed Expander, Group Conventional Expander

Maxillary Expansion Clinical Trial 2023: 3D-Printed Hyrax Expander Highlights & Side Effects. Trial Name: NCT05743127 — N/A

3D-Printed Hyrax Expander (Orthodontic Appliance) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05743127 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment include geriatric participants?

"The eligibility requirements for this medical trial stipulate that participants must be between 8 and 13 years old."

Answered by AI

Is this research project still accepting participants?

"At present, the medical trial posted on February 15th 2023 is not seeking participants. Clinicaltrials.gov states that this study has been inactive since February 14th 2023; however, four other studies are actively recruiting right now."

Answered by AI

Can I be admitted into this clinical experimentation?

"This clinical trial seeks 42 minors aged 8 to 13 who are afflicted with maxillary expansion. In addition, the individuals and their guardians must consent to participating in this study; be able to access an electronic device connected to the internet; and be orthodontic patients at Medical University of South carolina's Department of Orthodontics."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

Ildeu Andrade 2023. "3D-Printed Versus Laboratory-Fabricated Hyrax Expanders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05743127.