3D comparison of maxillary expansion methods in children
Official title: Three-Dimensional Evaluation of the Effects of Different Maxillary Expansion Methods
Run by Bezmialem Vakif University · NCT07262892 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 12 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Bezmialem Vakif University Academic / other |
| Locations | 1 site (Istanbul, Fatih) |
| Status | Recruiting |
| Started | November 20, 2025 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07262892 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are cooperative children aged 6–12 with maxillary transverse deficiency, good oral hygiene, and no previous maxillary expansion.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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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.