Palatal Expansion TechniqueNCT06414863
Effects of Invisalign Palatal Expander System
A study testing IPE and HE in people with Palatal Expansion Technique, run by University of the Pacific at 1 site in United States.
Trial summary
The aim of this study is to evaluate the effectiveness of Invisalign Palatal Expander system ingrowing patients. This study compares the treatment outcomes of Invisalign Palatal Expander system to conventional treatments through randomized controlled trial. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Palatal Expansion Technique
- What is being tested?
- IPE and HE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2024to 10 May 2034
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mixed dentition phase with at least three nonmobile (stable) teeth which have more than 1/4 of primary molar root length left16 in either side
- Early permanent dentition stage and early permanent dentition but second permanent molars not yet fully erupted in the arch
- Unilateral or bilateral posterior cross bite patients; or Patients who have been diagnosed with transverse maxillary deficiency (Skeletal transverse discrepancy measured from the estimated center of resistances of the first molars17 ≤ - 3 mm);
- Patients with Class I or Class II skeletal relationship
- Subjects willing to consent to the trial
Who cannot join
- Any general medical health problems which may influence treatment
- Any craniofacial anomalies
- Skeletal Class III patients
- Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of the Pacific
San Francisco, California, 94103
Heeyeon Suh, 415-351-7134, hsuh1@pacific.edu
About this study
Official title: Treatment Effects of Invisalign Palatal Expander System and Hyrax Palatal Expander - A Randomized Controlled Trial
The aim of this study is to evaluate the effectiveness of Invisalign Palatal Expander system ingrowing patients. This study compares the treatment outcomes of Invisalign Palatal Expander system to conventional treatments through randomized controlled trial.
- Conditions
- Palatal Expansion Technique
- Being tested
- IPE, HE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPEDevice
Invisalign palatal expander system:
The Invisalign® Palatal Expander System (AlignTechnology, inc.) is 3D-printed orthodontic device for maxillary expansion.
HEDevice
Hyrax expander:
The Hyrax-type maxillary expander will include a midline self-locking screw. The expansion screw is connected to the conventional molar bands or printed clasps, which are cemented on the maxillary first molars (or on the maxillary primary second molars), via 0.9 mm stainless-steel wire. The framework is soldered to the bands and extends on the palatal side to the primary canines or canines. The expander will be fabricated by a qualified laboratory technician
| Study group | Role | What they receive |
|---|---|---|
| Invisalign® Palatal Expander System | Experimental | Invisalign® Palatal Expander System will be delivered. Receives: Device: IPE |
| Hyrax-type maxillary expander | Active comparator | Hyrax-type maxillary expander will be delivered. The Hyrax-type maxillary expander will include a midline self-locking screw, which is connected to the conventional molar bands or printed clasps, which are cemented on the maxillary first molars (or on the maxillary primary second molars), via 0.9 mm stainless-steel wire. The framework is soldered to the bands and extends on the palatal side to the primary canines or canines. The expander will be fabricated by a qualified laboratory technician Receives: Device: HE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width change
Transverse changes on CBCTs
Measured: 12-18 months
Arch width change
Arch width change measured on digital study casts
Measured: 12-18 months
Secondary outcomes (1)
Cephalometric changes
Common Cephalometric measurements changes on CBCT analysis
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start10 May 2024 (estimated)
- Primary completion10 May 2028 (estimated)
- Study completion10 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palatal Expansion TechniqueStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heeyeon Suh, University of the Pacific
- Investigators
- Heeyeon Suh, Principal investigator, University of the Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414863
- Sponsor's protocol ID
- 2024-43
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effects of Invisalign Palatal Expander System and Hyrax Palatal Expander - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06414863
- Acronym / sponsor ID
- 2024-43
- Conditions
- Palatal Expansion Technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 10 May 2028 (estimated)
- Study completion
- 10 May 2034 (estimated)
- First posted
- 16 May 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 aim of this study is to evaluate the effectiveness of Invisalign Palatal Expander system ingrowing patients. This study compares the treatment outcomes of Invisalign Palatal Expander system to conventional treatments through randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invisalign® Palatal Expander System | Experimental | Device: IPEInvisalign® Palatal Expander System will be delivered. |
| Hyrax-type maxillary expander | Active comparator | Device: HEHyrax-type maxillary expander will be delivered. The Hyrax-type maxillary expander will include a midline self-locking screw, which is connected to the conventional molar bands or printed clasps, which are cemented on the maxillary first molars (or on the maxillary primary second molars), via 0.9 mm stainless-steel wire. The framework is soldered to the bands and extends on the palatal side to the primary canines or canines. The expander will be fabricated by a qualified laboratory technician |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Mixed dentition phase with at least three nonmobile (stable) teeth which have more than 1/4 of primary molar root length left16 in either side
- Early permanent dentition stage and early permanent dentition but second permanent molars not yet fully erupted in the arch
- Unilateral or bilateral posterior cross bite patients; or Patients who have been diagnosed with transverse maxillary deficiency (Skeletal transverse discrepancy measured from the estimated center of resistances of the first molars17 ≤ - 3 mm);
- Patients with Class I or Class II skeletal relationship
- Subjects willing to consent to the trial
Key exclusion criteria (4 listed)
- Any general medical health problems which may influence treatment
- Any craniofacial anomalies
- Skeletal Class III patients
- Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars.
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 |
|---|---|---|
| IPEInvisalign palatal expander system: The Invisalign® Palatal Expander System (AlignTechnology, inc.) is 3D-printed orthodontic device for maxillary expansion. | Device | Invisalign® Palatal Expander System |
| HEHyrax expander: The Hyrax-type maxillary expander will include a midline self-locking screw. The expansion screw is connected to the conventional molar bands or printed clasps, which are cemented on the maxillary first molars (or on the maxillary primary second molars), via 0.9 mm stainless-steel wire. The framework is soldered to the bands and extends on the palatal side to the primary canines or canines. The expander will be fabricated by a qualified laboratory technician | Device | Hyrax-type maxillary expander |
Primary outcome
Width change
Time frame: 12-18 months
Transverse changes on CBCTs
Arch width change
Time frame: 12-18 months
Arch width change measured on digital study casts
1 secondary outcome
Cephalometric changes
Time frame: 12-18 months
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 16 May 2024.
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Palatal Expansion Technique
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.
Heeyeon Suh principal investigator
University of the Pacific
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPE and HE in people with Palatal Expansion Technique, run by University of the Pacific at 1 site 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 5 inclusion and 4 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Heeyeon Suh (415-351-7134, hsuh1@pacific.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Width change (time frame: 12-18 months). The study lists 2 primary outcomes in all. 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 16 May 2024.