MalocclusionsNCT06662279
Hyrax Vs. Invisalign Palatal Expander Clinical Study
A study testing Removable Rapid Palatal Expander and Banded Palatal Expander in people with Malocclusions and Narrow Maxilla, run by Align Technology, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Malocclusions, Narrow Maxilla, Narrow Maxillary Arch
- What is being tested?
- Removable Rapid Palatal Expander and Banded Palatal Expander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Oct 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject ages 6-11 years old
- Subject must need maxillary expansion
- Subjects must have erupted dentition in the area of the primary molars or permanent premolars and the first permanent molar
Who cannot join
- Subjects with palatal exostosis/surface aberration/ cleft palate
- Subject's dentition not compatible with device or allergy to device materials
- Subject with active caries, periodontal disease, TMD
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sherri Wilson-Lopes contact
United States4 sites, 4 recruiting
- Recruiting
The Orthodontic Studio
Chevy Chase, Maryland, 20815
Dr. Jennifer Smith, DDS, 301-307-5115, drsmith@theorthostudiomd.com
- Recruiting
Orange Coast Orthodontics
Laguna Hills, California, 92653
Dr. Bobby Ghandehari, DDS, 949-305-0550, drbobby@orangecoastortho.com
- Recruiting
Innovative Orthodontic Centers
Naperville, Illinois, 60540
Dr. Manal Ibrahim, DDS, 630-848-6960, dribrahim@innovativeorthodonticconsultants.com
- Recruiting
Spillers Orthodontics
Warner Robins, Georgia, 31088
Dr. Don Spillers, DDS, 478-953-2700, don@drspillers.com
About this study
The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.
- Conditions
- Malocclusions, Narrow Maxilla, Narrow Maxillary Arch, Crowding
- Being tested
- Removable Rapid Palatal Expander, Banded Palatal Expander
- Medical subject headings
- Malocclusion, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removable Rapid Palatal ExpanderDevice
Removable palatal expander where expanders are changed to obtain up to .25mm expansion per expander
Banded Palatal ExpanderDevice
Palatal expander cemented into mouth where a screw is turned to obtain .25mm expansion per turn
| Study group | Role | What they receive |
|---|---|---|
| Invisalign Palatal Expander | Active comparator | Not described Receives: Device: Removable Rapid Palatal Expander |
| Hyrax Expander | Active comparator | Not described Receives: Device: Banded Palatal Expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
width of palate after expansion
intraoral scans will be taken of the subject's upper arch, including palate throughout the study and widths will be measured
Measured: from enrollment to study completion, approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start25 Oct 2024
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Align Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662279
- Sponsor's protocol ID
- A025375
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyrax Vs. Invisalign Palatal Expander Clinical Study
- ClinicalTrials.gov ID
- NCT06662279
- Acronym / sponsor ID
- A025375
- Conditions
- Malocclusions, Narrow Maxilla, Narrow Maxillary Arch, Crowding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Align Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invisalign Palatal Expander | Active comparator | Device: Removable Rapid Palatal Expander |
| Hyrax Expander | Active comparator | Device: Banded Palatal Expander |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject ages 6-11 years old
- Subject must need maxillary expansion
- Subjects must have erupted dentition in the area of the primary molars or permanent premolars and the first permanent molar
Key exclusion criteria (3 listed)
- Subjects with palatal exostosis/surface aberration/ cleft palate
- Subject's dentition not compatible with device or allergy to device materials
- Subject with active caries, periodontal disease, TMD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removable Rapid Palatal ExpanderRemovable palatal expander where expanders are changed to obtain up to .25mm expansion per expander | Device | Invisalign Palatal Expander |
| Banded Palatal ExpanderPalatal expander cemented into mouth where a screw is turned to obtain .25mm expansion per turn | Device | Hyrax Expander |
Primary outcome
width of palate after expansion
Time frame: from enrollment to study completion, approximately 4 months
intraoral scans will be taken of the subject's upper arch, including palate throughout the study and widths will be measured
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sherri Wilson-Lopes contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removable Rapid Palatal Expander and Banded Palatal Expander in people with Malocclusions and Narrow Maxilla, run by Align Technology, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Smita Sharma (408-470-4079, skaushik@aligntech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
width of palate after expansion (time frame: from enrollment to study completion, approximately 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.