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

Plain Language Summary

Simplified for easier understanding

This study is comparing different methods for expanding a narrow upper jaw (maxillary expansion) in children between 6 and 12 years old, using 3D imaging to evaluate how the jaw bone responds to each approach. **You may be eligible if...** - Your child is between 6 and 12 years old - Your child has good oral hygiene and is cooperative for dental treatment - Your child has not previously had orthodontic jaw expansion treatment **You may NOT be eligible if...** - Your child has a systemic disease affecting bone growth or jaw development (such as a bone metabolism disorder or craniofacial syndrome) - Your child has had previous orthodontic or orthopedic jaw expansion - Your child takes medications that affect bone metabolism - Your child has severe behavioral difficulties that would prevent treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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