Evaluating the effectiveness of the Invisalign Palatal Expander system
Official title: Treatment Effects of Invisalign Palatal Expander System and Hyrax Palatal Expander - A Randomized Controlled Trial
Run by University of the Pacific · NCT06414863 · Data updated 2026-11-12
This study tests if the Invisalign Palatal Expander can help kids and teens with certain dental issues grow their jaws better than traditional methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 14 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of the Pacific Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | May 10, 2024 |
| Main results expected | May 10, 2028 |
| Study ends | May 10, 2034 |
| Registry record updated | May 16, 2024 |
| Trial ID | NCT06414863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children in the mixed dentition phase or early permanent dentition stage with specific dental issues like unilateral or bilateral posterior crossbites.
✕Probably not a fit
Patients with general medical health problems, craniofacial anomalies, or those with a skeletal Class III relationship may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the effectiveness of the Invisalign Palatal Expander system in growing patients by comparing its treatment outcomes to conventional methods. It employs a randomized controlled trial design to ensure robust results. The focus is on patients with specific dental conditions, particularly those requiring palatal expansion due to transverse maxillary deficiency. The study will include participants in the mixed dentition phase or early permanent dentition stage.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more effective alternative for palatal expansion in children and adolescents.
How similar studies have gone: While there is limited information on the success of similar studies, the use of innovative orthodontic devices like the Invisalign system has shown promise in other contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: 1. 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 2. Early permanent dentition stage and early permanent dentition but second permanent molars not yet fully erupted in the arch 3. 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); 4. Patients with Class I or Class II skeletal relationship 5. Subjects willing to consent to the trial Exclusion Criteria: 1. Any general medical health problems which may influence treatment 2. Any craniofacial anomalies 3. Skeletal Class III patients 4. Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars.
Where it's running
-
University of the Pacific
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Heeyeon Suh — University of the Pacific
- Study coordinator: Heeyeon Suh
- Email: hsuh1@pacific.edu
- Phone: 415-351-7134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.