3D comparison of maxillary expansion methods in children
Three-Dimensional Evaluation of the Effects of Different Maxillary Expansion Methods
This project tests whether the Invisalign Palatal Expander or traditional rapid maxillary expansion better widens the upper jaw in children with maxillary transverse deficiency.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Bezmialem Vakif University Academic / other |
| Locations | 1 site (Istanbul, Fatih) |
| Trial ID | NCT07262892 on ClinicalTrials.gov |
What this trial studies
This controlled prospective trial will enroll 60 children aged 6–12 and allocate 20 each to an Invisalign Palatal Expander (IPE) group, an acrylic cap-splint rapid maxillary expansion (RME) group, and an untreated control group. Three-dimensional intraoral and extraoral scans will be taken at the end of expansion, and at three and six months to create digital models. Primary measures include maxillary arch width, first molar angulation, palatal surface area, and palatal volume, while secondary outcomes assess facial soft tissue changes. Group comparisons will use standard statistical tests to directly contrast a traditional mechanical expander with a modern digitally produced removable device.
Who should consider this trial
Good fit: Ideal candidates are cooperative children aged 6–12 with maxillary transverse deficiency, good oral hygiene, and no previous maxillary expansion.
Not a fit: Children with craniofacial syndromes, systemic conditions affecting bone growth, prior maxillary expansion, or older patients with fused palatal sutures are unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, the results could help clinicians choose the expansion method that achieves better arch widening with fewer side effects and simpler hygiene for children.
How similar studies have performed: Traditional RME has an established evidence base for skeletal widening, while IPE is a newer digital approach and direct pediatric head-to-head comparisons are scarce.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 6-12 years * Good oral hygiene and adequate patient cooperation * No previous orthodontic expansion treatment Exclusion Criteria: * Systemic diseases affecting growth, bone metabolism, or craniofacial development * Craniofacial syndromes or congenital anomalies * Severe behavioral or cooperation problems * Previous orthodontic or orthopedic maxillary expansion * Patients undergoing medications that affect bone metabolism
Where this trial is running
Istanbul, Fatih
- Bezmialem Vakif University — Istanbul, Fatih, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Banu Kılıç, Associate Professor
- Email: bkilic@bezmialem.edu.tr
- Phone: +90 532 243 2756
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.