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RECRUITING
NCT07262892
NA

3D Evaluation of Maxillary Expansion Methods

Sponsor: Büşra Zeynep Yörük

View on ClinicalTrials.gov

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.

Official title: Three-Dimensional Evaluation of the Effects of Different Maxillary Expansion Methods

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-11-20

Completion Date

2026-06

Last Updated

2025-12-04

Healthy Volunteers

Yes

Interventions

DEVICE

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.

DEVICE

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.

Locations (1)

Bezmialem Vakif University

Istanbul, Fatih, Turkey (Türkiye)