3D-Printed vs Conventional Hyrax Expanders for Maxillary Expansion

Recruiting at 1 trial location

Overseen By Ildeu Andrade, DDS, MS, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ildeu Andrade Jr.

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two orthodontic devices for widening the upper jaw in children, focusing on comfort and effectiveness. The Conventional Laboratory Fabricated Hyrax Expander is handmade in a lab, while the 3D-Printed Hyrax Expander uses 3D printing technology. Participants will be randomly assigned to use either the traditional or 3D-printed expander and will provide feedback on comfort and any pain experienced. Children aged 8-13 with specific dental needs, such as a narrow upper jaw or misaligned bite, and who have not undergone previous orthodontic treatment, may be suitable candidates. The study aims to determine if the 3D-printed version could offer a better option for future treatments. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative orthodontic research that could enhance future treatments.

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 prior data suggests that these maxillary expanders are safe for children?

Research shows that both 3D-printed and traditional Hyrax expanders are safe for orthodontic treatments. Studies indicate that patients generally tolerate 3D-printed expanders well. Digital planning of these expanders has been associated with good results, and few safety concerns arise during treatment.

For traditional Hyrax expanders, some studies have found minor issues. One study comparing different expanders reported that about 17.8% of patients experienced unwanted effects, such as uneven expansion, pain, and dental problems. However, these issues are common in orthodontic treatments and are usually manageable.

Both types of expanders are already used in clinics, suggesting that orthodontists consider them safe. While some reports mention discomfort and minor complications, these treatments are generally considered safe for children needing jaw expansion. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for maxillary expansion because they explore innovative ways to widen the upper jaw. The 3D-Printed Hyrax Expander offers a modern twist on this orthodontic approach by using advanced printing technology to create a custom fit, potentially improving comfort and efficiency over traditional options. This method could streamline production times and allow for personalization that isn't possible with conventional laboratory-fabricated expanders. By comparing these two methods, researchers hope to determine if 3D printing can enhance patient outcomes and transform standard practices in orthodontics.

What evidence suggests that this trial's expanders could be effective for maxillary expansion?

This trial will compare the effectiveness of 3D-Printed Hyrax Expanders with Conventional Laboratory Fabricated Hyrax Expanders for maxillary expansion. Research comparing different types of Hyrax expanders has shown that both 3D-printed and traditional versions effectively widen the upper jaw. Participants in this trial may receive the 3D-printed expanders, which studies have found to work well for treating jaw width issues, with some noting they are comfortable to wear. However, about 17.8% of patients experienced problems like uneven expansion and discomfort. Alternatively, participants may receive traditional expanders, known for reliably increasing jaw width over time. Both methods show promise, but each has its own advantages and possible downsides. ^{3 6 7 8 9}

Who Is on the Research Team?

Ildeu Andrade, DDS, MS, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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

Patients with a history of temporomandibular disorders

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

Presence of congenitally missing teeth

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 3D-Printed Hyrax Expander
• Conventional Laboratory Fabricated Hyrax Expander

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.

How Is the Trial Designed?

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+

American Association of Orthodontics Foundation

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

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]

In a study of 40 growing patients with Class III malocclusion, the use of hybrid hyrax (HH) expanders resulted in a significantly higher frequency of overjet correction (94.4%) compared to conventional hyrax (CH) expanders (71.4%).

Both HH and CH expanders produced similar skeletal effects, but the HH group showed better control over the mesial displacement of maxillary first molars during treatment, indicating a potential advantage in using HH expanders for maxillary protraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dentoskeletal comparison of miniscrew-anchored maxillary protraction with hybrid and conventional hyrax expanders: A randomized clinical trial. Miranda, F., Cunha Bastos, JCD., Magno Dos Santos, A., et al.[2023]

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]

The Hyrax appliance was associated with higher self-perceived pain levels compared to the Haas appliance, but this difference was only significant on the first day of treatment, indicating that initial discomfort may be a temporary issue.

Overall, the evidence regarding pain levels among different maxillary expansion appliances is inconclusive, as some studies found no significant differences in pain intensity between the Hyrax and other appliances, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-perceived pain in Hyrax versus other maxillary expansion orthodontic appliances: a systematic review of clinical studies. Altuhafy, M., Jabr, L., Michelogiannakis, D., et al.[2023]

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]

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 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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthopedic outcomes of hybrid and conventional Hyrax expanders. Garib, D., Miranda, F., Palomo, JM., et al.[2023]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10944817/

Comparison of 3D-printed and laboratory-fabricated Hyrax ... Since the 3D-printed expanders promise to be effective in treating transverse maxillary deficiencies, there is a need to verify their ...

2. withpower.com withpower.com/trial/phase-maxillary-expansion-1-2023-8a15c

3D-Printed vs Conventional Hyrax Expanders for Maxillary ... In a study comparing different types of Hyrax expanders, 17.8% of patients experienced some undesired outcomes, such as asymmetric expansion, pain, dental ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1013905223002377

Impact of digital orthodontics on maxillary protraction with ... The outcomes included the efficacy of the digital orthodontic interventions, the ease of the procedures, the ease of surgical procedures, the time required for ...

4. trial.medpath.com trial.medpath.com/clinical-trial/4116bc7eb88b9c82/nct05743127-3d-printed-vs-laboratory-fabricated-hyrax-expanders

3D-Printed Versus Laboratory-Fabricated Hyrax Expanders 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 ...

5. researchgate.net researchgate.net/publication/379044731_Comparison_of_3D-printed_and_laboratory-fabricated_Hyrax_on_stress_distribution_and_displacement_of_the_maxillary_complex_a_3D_finite_element_study

Comparison of 3D-printed and laboratory-fabricated Hyrax ... Objective To analyze and compare the effects of a traditional laboratory-fabricated Hyrax expander (T-Hyrax) and two different 3D-printed ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1073874623000014

3D Metal Printing in Orthodontics: Current Trends ... ... 3D printed Hyrax was tested for its yield strength in three patients requiring expansion. In all these patients a similar protocol for bonding of the Hyrax ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10897631/

Impact of digital orthodontics on maxillary protraction with ... Digital planning was associated with a positive outcome for maxillary expansion and protraction with minimal safety concerns. Treatment successfully ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06414863

Effects of Invisalign Palatal Expander System This study compares the treatment outcomes of Invisalign Palatal Expander system to conventional treatments through randomized controlled trial. Official Title.

9. mdpi.com mdpi.com/2076-3417/15/1/78

3D-Printed Accessories and Auxiliaries in Orthodontic ... It was demonstrated that satisfying results of maxillary protraction with digital protocol improved the speed and safety of the treatment, while also improving ...