3D-Printed vs Conventional Hyrax Expanders for Maxillary Expansion

Recruiting at1 trial location

Overseen by Ildeu Andrade, DDS, MS, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ildeu Andrade Jr.

Disqualifiers: Previous orthodontics, TMJ disorders, craniofacial syndromes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares two types of devices used to widen the upper jaw in children aged 8-13: one made by hand and one made with a 3D printer. The goal is to see if the 3D-printed device works as well and is more comfortable. Children will use one of the devices, and their progress will be monitored for several months.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on orthodontic treatment, so it's unlikely that medications would be affected, but you should confirm with the study team.

What data supports the effectiveness of the 3D-Printed Hyrax Expander treatment?

Research comparing different types of Hyrax expanders, including conventional ones, shows they are effective in expanding the upper jaw in patients with jaw discrepancies. The studies suggest that Hyrax expanders, in general, are effective for maxillary expansion, which supports the potential effectiveness of the 3D-Printed version. ^{1 2 3 4 5}

Is the use of 3D-Printed or Conventional Hyrax Expanders generally safe for humans?

In a study comparing different types of Hyrax expanders, 17.8% of patients experienced some undesired outcomes, such as asymmetric expansion, pain, dental darkening requiring root canal treatment, and local infection. However, the number and severity of these complications were similar between the different types of expanders used. ^{1 3 4 5 6}

How does the 3D-Printed Hyrax Expander treatment differ from other treatments for maxillary expansion?

The 3D-Printed Hyrax Expander is unique because it uses advanced 3D printing technology to create a custom-fit device for maxillary expansion, potentially offering more precise and personalized treatment compared to conventional laboratory-fabricated expanders. This approach may improve the fit and effectiveness of the expander, leading to better outcomes in expanding the upper jaw. ^{1 3 7 8 9}

Research Team

Ildeu Andrade, DDS, MS, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

I am between 8 and 13 years old.

I have a narrow upper jaw with or without a crossbite.

I am a child aged 12-13 and agree to participate in the study.

Exclusion Criteria

My parents have a strong preference for the type of expander used in my treatment.

Patients with a history of temporomandibular disorders

Presence of congenitally missing teeth

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either a 3D-Printed or Conventional Laboratory Fabricated Hyrax Expander

6 months

Standard clinical follow-up visits including photos, x-rays, and dental photo scans

Follow-up

Participants are monitored for changes in dental measurements and quality of life through online questionnaires

2 weeks

Treatment Details

Interventions

• 3D-Printed Hyrax Expander (Orthodontic Appliance)
• Conventional Laboratory Fabricated Hyrax Expander (Orthodontic Appliance)

Trial Overview 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.

Participant Groups

Group I: Group Conventional Expander Experimental Treatment 1 Intervention

Conventional Laboratory Fabricated Hyrax Expander

Group II: Group 3-D Printed Expander Experimental Treatment 1 Intervention

3D-Printed Hyrax Expander

Who Is Running the Clinical Trial?

Ildeu Andrade Jr.

Lead Sponsor

Trials

2

Recruited

70+

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Dr. Erik Summers

Medical University of South Carolina

Chief Medical Officer

MD from University of Alabama at Birmingham

Dr. Patrick J. Cawley

Medical University of South Carolina

Chief Executive Officer

MD, MBA

American Association of Orthodontics Foundation

Collaborator

Trials

1

Recruited

40+

Findings from Research

In a study of 50 growing patients with maxillary narrowness, both the modified Hyrax rapid palatal expander and the standard Hyrax expander effectively corrected maxillary deficiencies, but the modified version showed superior results in restoring midline symmetry.

The modified Hyrax expander achieved a midline correction of nearly 5-6 mm and created 7-9 mm of additional space in the canine area, making it a better option for addressing upper midline deviations compared to the standard expander.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the dental and skeletal effects of two different rapid palatal expansion appliances for the correction of the maxillary asymmetric transverse discrepancies. Farronato, G., Giannini, L., Galbiati, G., et al.[2012]

The study used finite element modeling to analyze how different positions of the expansion screw on a hyrax expander affect stress distribution in the maxillary bone, revealing that stress is concentrated near the incisive foramen and dissipates towards the pterygoid pillars.

Positioning the expansion screw closer to the occlusal plane and more anteriorly was found to be more effective in transferring mechanical forces to the bone, suggesting optimal placement can enhance the efficacy of the expander in orthodontic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of the hyrax expander screw position on stress distribution in the maxilla: A study with finite elements. Fernandes, LC., Farinazzo Vitral, RW., Noritomi, PY., et al.[2019]

In a study of 90 patients undergoing surgically assisted rapid maxillary expansion (SARME) with either HAAS or HYRAX expanders, 17.8% experienced at least one undesired outcome, with no significant difference in complications between the two types of expanders.

The most common complications included radiographic asymmetric expansion and dental darkening, indicating that while both expanders are generally safe, careful monitoring for these specific issues is necessary during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications From Surgically Assisted Rapid Maxillary Expansion With HAAS and HYRAX Expanders. Pereira, MD., Koga, AF., Prado, GPR., et al.[2018]

The study used finite element modeling to evaluate how different heights of the hyrax expander screw affect dental inclination during rapid maxillary expansion, revealing that screw height significantly influences tooth movement.

Positioning the screw slightly above the center of resistance of the maxillary first molars may minimize unwanted dental tipping, suggesting that careful planning of screw height is crucial for effective orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of the expansion screw height on the dental effects of the hyrax expander: a study with finite elements. Araugio, RM., Landre, J., Silva, Dde L., et al.[2022]

Laser holography revealed micro-displacements in the craniofacial bones during midpalatal expansion, helping to define the centers of rotation for maxillary halves, which is crucial for understanding the mechanics of the Hyrax appliance.

The study suggests using larger diameter stainless steel wires and increasing the diameter of the activating screw in the Hyrax device to improve biomechanical efficiency, while advising against using acrylic for structural connections to minimize tipping of the maxillary halves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The biomechanics of rapid maxillary sutural expansion. Braun, S., Bottrel, JA., Lee, KG., et al.[2022]

In a study of 75 patients with bilateral cleft lip and palate, maxillary expansion using Quad-helix and differential opening expanders resulted in significant changes in dental arch shape after 6 months, while the Hyrax expander did not alter the shape.

All three expanders showed no significant differences in dental arch size, but the Quad-helix and differential opening expanders produced greater increases in intercanine width compared to intermolar width, indicating their effectiveness in reshaping the dental arch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental arch size and shape after maxillary expansion in bilateral complete cleft palate: A comparison of three expander designs. Pugliese, F., Palomo, JM., Calil, LR., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Orthopedic outcomes of hybrid and conventional Hyrax expanders. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Comparison of the dental and skeletal effects of two different rapid palatal expansion appliances for the correction of the maxillary asymmetric transverse discrepancies. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Influence of the hyrax expander screw position on stress distribution in the maxilla: A study with finite elements. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Self-perceived pain in Hyrax versus other maxillary expansion orthodontic appliances: a systematic review of clinical studies. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Complications From Surgically Assisted Rapid Maxillary Expansion With HAAS and HYRAX Expanders. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Dentoskeletal comparison of miniscrew-anchored maxillary protraction with hybrid and conventional hyrax expanders: A randomized clinical trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Influence of the expansion screw height on the dental effects of the hyrax expander: a study with finite elements. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The biomechanics of rapid maxillary sutural expansion. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Dental arch size and shape after maxillary expansion in bilateral complete cleft palate: A comparison of three expander designs. [2021]