Evaluating the effectiveness of the Invisalign Palatal Expander system
Treatment Effects of Invisalign Palatal Expander System and Hyrax Palatal Expander - A Randomized Controlled Trial
NA · University of the Pacific · NCT06414863
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 6 Years to 14 Years |
| Sex | All |
| Sponsor | University of the Pacific (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06414863 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Palatal Expansion Technique