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RecruitingNot ApplicableNCT07262892

3D Evaluation of Maxillary Expansion Methods

Three-Dimensional Evaluation of the Effects of Different Maxillary Expansion Methods

Sponsor

Büşra Zeynep Yörük

Enrollment

60 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Maxillary Transverse Deficiency

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

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria3

  • Children aged 6-12 years
  • Good oral hygiene and adequate patient cooperation
  • No previous orthodontic expansion treatment

Exclusion Criteria5

  • 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

Interventions

DEVICEInvisalign 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.

DEVICEAcrylic 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)

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NCT07262892