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

Trial Summary

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 data supports the effectiveness of the treatment Hyrax Expander 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 improve alignment. It is particularly effective in young patients with certain dental conditions, such as maxillary hypoplasia (underdeveloped upper jaw), and can reduce the time needed for braces. ^{1 2 3 4 5}

Is the Hyrax palatal expander safe for humans?

The Hyrax palatal expander is generally considered safe for humans, with studies showing it effectively expands the palate without significant complications. However, it may cause some tipping of teeth and increased mobility, which are common and manageable side effects. ^{1 2 3 6 7}

How is the Hyrax Expander treatment different from other treatments for misaligned teeth?

The Hyrax Expander treatment is unique because it uses a rapid palatal expansion technique to widen the upper jaw, which can help correct misaligned teeth by creating more space. Unlike some other treatments, it can be used in patients with mixed dentition and can reduce the duration of orthodontic therapy with fixed appliances. ^{1 2 3 5 7}

What is the purpose of this trial?

The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Hyrax Expander Active Control 1 Intervention

Group II: Invisalign Palatal 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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Upper midline deviation: modified Hyrax expander. [2019]

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

Modified Hyrax expander for the correction of upper midline deviation: a case report. [2011]

3. England pubmed.ncbi.nlm.nih.gov

Surgically assisted rapid palatal expansion with tent screws and a custom-made palatal expander: a case report. [2020]

4. 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]

5. France pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

A comparison of dentoalveolar inclination treated by two palatal expanders. [2022]

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

Two-point rapid palatal expansion: an alternate approach to traditional treatment. [2006]