42 Participants Needed

3D-Printed vs Conventional Hyrax Expanders for Maxillary Expansion

Recruiting at 1 trial location
IA
Overseen ByIldeu Andrade, DDS, MS, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Ildeu Andrade Jr.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.13456

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.13789

Research Team

IA

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.
See 3 more

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
See 3 more

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
  • Conventional Laboratory Fabricated Hyrax Expander
Trial OverviewThe 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
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

Find a Clinic Near You

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+

American Association of Orthodontics Foundation

Collaborator

Trials
1
Recruited
40+

Findings from Research

In a study of 40 growing patients, the hybrid miniscrew-supported Hyrax (HH) expander resulted in significantly greater increases in nasal cavity width, maxillary width, and buccal alveolar crest width compared to the conventional Hyrax (CH) expander after 11 months.
However, both expanders produced similar changes in dental arch width and shape, indicating that while the HH expander may enhance certain orthopedic effects, overall arch size and shape remain comparable between the two methods.
Orthopedic outcomes of hybrid and conventional Hyrax expanders.Garib, D., Miranda, F., Palomo, JM., et al.[2023]
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.
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.
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]

References

Orthopedic outcomes of hybrid and conventional Hyrax expanders. [2023]
Comparison of the dental and skeletal effects of two different rapid palatal expansion appliances for the correction of the maxillary asymmetric transverse discrepancies. [2012]
Influence of the hyrax expander screw position on stress distribution in the maxilla: A study with finite elements. [2019]
Self-perceived pain in Hyrax versus other maxillary expansion orthodontic appliances: a systematic review of clinical studies. [2023]
Complications From Surgically Assisted Rapid Maxillary Expansion With HAAS and HYRAX Expanders. [2018]
Dentoskeletal comparison of miniscrew-anchored maxillary protraction with hybrid and conventional hyrax expanders: A randomized clinical trial. [2023]
Influence of the expansion screw height on the dental effects of the hyrax expander: a study with finite elements. [2022]
The biomechanics of rapid maxillary sutural expansion. [2022]
Dental arch size and shape after maxillary expansion in bilateral complete cleft palate: A comparison of three expander designs. [2021]