What side effects are associated with this type of intervention?

Common treatments for maxillary expansion, such as laboratory-fabricated and 3D-printed expanders, can have side effects including discomfort, pain, and pressure in the upper jaw. Patients may also experience temporary difficulties with speech and eating. Additionally, there is a risk of teeth tipping and minor irritation to the gums and soft tissues. Regular follow-up with an orthodontist is essential to monitor progress and manage any adverse effects.

What prior FDA approvals exist?

Maxillary expansion is typically achieved using orthodontic devices known as maxillary expanders, which can be either laboratory-fabricated or 3D-printed. These devices are used to widen the upper jaw in children and are regulated as medical devices by the FDA. There are no specific drugs approved for maxillary expansion, as the treatment relies on the physical action of the expanders. The study compares traditional laboratory-made expanders with newer 3D-printed versions to evaluate their effectiveness and patient comfort.

What other types of research exist?

Promising, novel alternatives to traditional maxillary expanders for 2024 include 3D-printed maxillary expanders, which are designed using computer-aided design (CAD) and produced with 3D printing technology. These expanders aim to provide effective jaw expansion with potentially greater comfort and customization for the patient. Other emerging technologies in orthodontics, such as clear aligners with expansion capabilities and minimally invasive surgical techniques, may also offer innovative solutions for maxillary expansion.

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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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Maxillary expanders, whether laboratory-fabricated or 3D-printed, work by applying lateral forces to the maxillary bones, causing them to separate at the mid-palatal suture. This separation allows new bone to form in the created gap, effectively widening the upper jaw. This mechanism is essential for patients as it helps correct crossbites, provides space for crowded teeth, and improves dental arch alignment, enhancing both oral function and aesthetics.

Biomechanical considerations for orthodontic treatment of adults.

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Who is running the clinical trial?

American Association of Orthodontics FoundationUNKNOWN

Medical University of South CarolinaLead Sponsor

941 Previous Clinical Trials

7,397,184 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

~2 spots leftby Aug 2024

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