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3D Evaluation of Maxillary Expansion Methods

RecruitingNAAges 6 Years - 12 YearsAllBüşra Zeynep Yörük
NCT07262892 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Invisalign Palatal Expander (IPE)
  • Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance
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Where

1 site
Bezmialem Vakif University
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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