Palatal Expanders for Misaligned Teeth

Recruiting at 3 trial locations

Overseen By Sherri Wilson-Lopes

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Align Technology, Inc.

Disqualifiers: Cleft palate, Active caries, Periodontal disease, TMD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the Invisalign Palatal Expander and the Hyrax Expander to determine which device more effectively corrects misaligned teeth. The focus is on identifying which expander provides better results and user experience. The trial seeks children aged 6-11 who need to widen their upper jaw and have specific adult teeth, such as the first molar, already grown in. Children with certain dental issues or allergies to the device materials may not be eligible to participate. As an unphased trial, this study offers participants a unique opportunity to contribute to dental research and potentially benefit from innovative treatment options.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these palatal expanders are safe for correcting misaligned teeth?

Research has shown that the Hyrax expander effectively fixes crooked teeth by widening the upper jaw. It has been used for many years and is generally considered safe, with studies finding no major safety issues.

The Invisalign Palatal Expander offers a newer option. Research indicates it serves as a removable and safe alternative to traditional expanders. Testing has confirmed its effectiveness and safety for widening the upper jaw.

In summary, both the Hyrax and Invisalign expanders are safe and effective for widening the upper jaw to correct crooked teeth, with no significant safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Invisalign Palatal Expander and the Hyrax Expander because these treatments offer innovative approaches to addressing misaligned teeth. The Invisalign Palatal Expander stands out because it is a clear, removable aligner, making it more discreet and comfortable compared to traditional metal expanders. This could be particularly appealing to patients seeking a less noticeable option. On the other hand, the Hyrax Expander is a fixed device known for its effectiveness in rapidly widening the upper jaw, which can significantly speed up treatment time. Both expanders bring distinct advantages, potentially improving patient comfort and treatment efficiency compared to conventional options like braces and fixed metal expanders.

What evidence suggests that this trial's treatments could be effective for misaligned teeth?

This trial will compare the Hyrax Expander and the Invisalign Palatal Expander for treating misaligned teeth. Studies have shown that the Hyrax Expander effectively widens the upper jaw, creating more space for teeth to align properly and improving the fit of teeth and jaw. Meanwhile, research indicates that the Invisalign Palatal Expander also effectively expands the upper jaw, with about 79.75% efficiency at the point where the canine teeth meet. Known for its comfort, this system matches the effectiveness of traditional methods. Both treatments provide good options for correcting misalignment, each offering distinct benefits. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with misaligned teeth conditions like malocclusion or crowded teeth. Specific eligibility details are not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

I need treatment to widen my upper jaw.

My back teeth, including the first big molar, have come in.

I am between 6 and 11 years old.

Exclusion Criteria

Subject's dentition not compatible with device or allergy to device materials

I have active tooth decay, gum disease, or jaw joint disorder.

I have a bone growth or abnormality in the roof of my mouth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Invisalign Palatal Expander or the Hyrax Expander

4 months

Regular visits for intraoral scans

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyrax Expander
• Invisalign Palatal Expander

Trial Overview The clinical study aims to compare two types of dental devices: the Invisalign Palatal Expander and the Hyrax expander. It will assess which device provides better results in expanding the palate and improving patient experience.

How Is the Trial Designed?

Group I: Invisalign Palatal Expander Active Control 1 Intervention

Group II: Hyrax Expander Active Control 1 Intervention

Hyrax Expander is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hyrax Rapid Palatal Expander for:

• Maxillary expansion for orthodontic purposes
• Correction of crossbite
• Treatment of crowding

Approved in European Union as Hyrax Rapid Palatal Expander for:

• Orthodontic maxillary expansion
• Correction of transverse maxillary deficiency
• Treatment of dental crowding

Approved in Canada as Hyrax Rapid Palatal Expander for:

• Maxillary expansion for orthodontic purposes
• Correction of crossbite
• Treatment of crowding

Who Is Running the Clinical Trial?

Align Technology, Inc.

Lead Sponsor

Trials

10

Recruited

1,100+

Published Research Related to This Trial

The modified Hyrax rapid palatal expander effectively treats maxillary hypoplasia in mixed dentition patients by restoring transverse maxillary dimensions and creating space for permanent teeth, as demonstrated in a case report.

This device not only corrects asymmetries and restores midline symmetry but also reduces the overall duration of subsequent orthodontic treatment with fixed appliances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Hyrax expander for the correction of upper midline deviation: a case report. Farronato, G., Giannini, L., Galbiati, G., et al.[2011]

In a study of 39 patients aged 11 to 16, both Hyrax and acrylic-bonded palatal expanders caused significant buccal tipping of molar crowns and alveolar processes during rapid maxillary expansion.

The Hyrax appliance resulted in greater dentoalveolar tipping compared to the acrylic-bonded appliance, indicating that the type of expander used can influence the degree of dental movement during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of dentoalveolar inclination treated by two palatal expanders. Kiliç, N., Kiki, A., Oktay, H.[2022]

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 modified Hyrax rapid palatal expander is effective for treating maxillary hypoplasia and asymmetric transverse discrepancies in patients with mixed dentition, particularly those with premature loss of deciduous teeth.

This appliance not only facilitates rapid expansion of the palate but also helps to shorten the overall duration of subsequent orthodontic treatments with fixed appliances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper midline deviation: modified Hyrax expander. Farronato, G., Giannini, L., Galbiati, G., et al.[2019]

A custom-made palatal expander using 4 tent screws was successfully used in a 23-year-old patient for surgically assisted rapid maxillary expansion, providing a stable and predictable method for expanding the dental arch.

This technique avoids the complications associated with traditional tooth-borne appliances, such as tooth tipping and increased mobility, making it a safer option for patients with periodontal issues or insufficient tooth anchorage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgically assisted rapid palatal expansion with tent screws and a custom-made palatal expander: a case report. Park, KN., Lee, CY., Park, IY., et al.[2020]

A new rapid palatal expander (two-point RPEe) using only two anchor teeth was found to be as effective as the traditional Hyrax appliance in expanding the maxillary posterior teeth in a study of 50 children aged 7 to 15 years.

The two-point RPEe caused less movement of the maxillary anterior and mandibular teeth compared to the Hyrax appliance, suggesting it may be a better option in specific clinical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-point rapid palatal expansion: an alternate approach to traditional treatment. Schneidman, E., Wilson, S., Erkis, R.[2006]

The Leaf expander (LEX) resulted in more overall tooth movement compared to the conventional Hyrax expander (HEX), particularly in the maxillary canines and premolars, while causing less tipping in the maxillary molars.

In the mandible, LEX led to a greater increase in arch widths and tipping of molars and second premolars, indicating that LEX may be more effective for certain dental movements in growing patients with transverse discrepancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyrax versus Leaf expander in growing patients, what about adverse dental effects? A retrospective study. Benhamour, S., Brezulier, D.[2023]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK592395/

Orthodontics, Malocclusion - StatPearls - NCBI Bookshelf Ackerman and Profitt's classification system for malocclusion is used to classify and describe different types of misalignment of the teeth and ...

2. withpower.com withpower.com/trial/palatal-expanders-for-misaligned-teeth-09320

Palatal Expanders for Misaligned Teeth Research shows that the Hyrax rapid palatal expander can help correct misaligned teeth by expanding the upper jaw, which can create more space for teeth and ...

3. medicaljournalssweden.se medicaljournalssweden.se/actaodontologica/article/download/44580/51203

The three-dimensional influence and clinical significance ... When the relationship between the dental arch and the jaw is misaligned, it can disrupt the normal ... Rapid maxillary expansion using a Hyrax-type appliance.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1073874624000616

Rapid maxillary expansion in early mixed dentition with a ... This review focuses on the effect of the treatment performed specifically in the early mixed dentition by using a tissue-borne Haas expander anchored onto the ...

5. researchgate.net researchgate.net/publication/354271946_Mini_Hyrax_vs_Hyrax_expanders_in_the_rapid_palatal_expansion_in_adolescents_with_posterior_crossbite_a_randomized_controlled_clinical_trial

(PDF) Mini Hyrax vs Hyrax expanders in the rapid palatal ... Among adolescents in the Hyrax group, a statistically significant reduction between 48 and 72 h was observed. Conclusion There were no significant differences ...

6. researchgate.net researchgate.net/figure/Three-different-types-of-palatal-expander-a-Hyrax-expander-b-Rep-on-mini-screws_fig2_372603634

Three different types of palatal expander: (a) Hyrax expander Even though they are often asymptomatic, odontomas can result in serious dental issues such impaction, misalignment, and delayed tooth eruption, which calls for ...

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

3D-Printed vs Conventional Hyrax Expanders for Maxillary ... 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.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232887.pdf

K232887 - Sindhura Gaddamanugu - accessdata.fda.gov The Invisalign Palatal Expander System is intended for use in the treatment of dental and/or skeletal malocclusion in primary, mixed or ...

9. investor.aligntech.com investor.aligntech.com/news-releases/news-release-details/invisalignr-palatal-expander-system-align-technology-now-1

Invisalign® Palatal Expander System by ... Invisalign® Palatal Expanders offer doctors a removeable, safe, and clinically effective alternative to traditional palatal expanders.