3D Evaluation of Maxillary Expansion Methods

Condition(s) studied

Investigational drug(s) / intervention(s)

Invisalign Palatal Expander (IPE): A removable, nylon palatal expander produced via digital workflow and 3D printing. Activations are planned at 0.25 mm per activation according to manufacturer protocol. Device is fitted to palatal curvature and used until desired expansion achieved, followed by retention.

Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance: Bonded acrylic cap splint RME with a jackscrew activated typically at 0.5 mm per day until expansion goal is reached, followed by retention period. Used in pediatric orthodontic practice.

Study summary

This controlled prospective clinical trial aims to evaluate the effectiveness of different maxillary expansion methods in children with maxillary transverse deficiency. A total of 60 participants will be included: 20 patients will receive Invisalign Palatal Expander (IPE), 20 will receive acrylic cap splint Rapid Maxillary Expansion (RME), and 20 will serve as an untreated control group. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. Primary outcomes include maxillary arch width, first molar angulation, palatal surface area, and palatal volume. Secondary outcomes include soft tissue changes in the facial region. This study provides a direct comparison between a traditional and a modern digital expansion method, generating evidence for clinical decision-making in pediatric orthodontics.

Eligibility

Primary outcome measure(s)

• Change in Maxillary First Molar Tipping — Baseline (T0), 3 months after expansion (T1), and 6-month retention period (T2)
  The angulation of the maxillary first molars will be measured using three-dimensional digital models obtained at T0, at 3 months after completion of expansion (T1), and at the 6-month retention follow-up (T2). Angular changes will be calculated through superimposition of maxillary 3D models and standardized angular measurements.

Trial sites (1)

Other trials for the same condition