Clinical Trial

Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances

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Record status
This record was last updated May 20, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to determine whether two types of rapid maxillary expansion (RME) appliances produce different outcomes in children. RME is a treatment utilized to expand a narrow upper jaw. This study will include children aged 8 to 10 years who need upper jaw expansion during the mixed dentition period (when they have both temporary and permanent teeth). The main questions this study aims to answer are: * Do 3D-printed expansion appliances produce different skeletal and dental changes compared to conventionally fabricated appliances? * Do children feel more comfortable with one type of appliance? * Is there a difference in pain levels or oral hygiene between the two groups? Researchers aimed to compare a conventionally fabricated expansion appliance manufactured in a dental laboratory with a 3D-printed expansion appliance produced digitally to determine whether the method of production affects treatment outcomes and patient comfort. Participants: * Being treated with one of the two expansion appliances (assigned randomly) * Follow a standard activation protocol at home with parental guidance * Attend regular clinic visits during expansion and retention phases * Have dental photographs, X-rays, and digital scans taken before and after treatment * Complete an oral health-related quality of life questionnaire * Rate their pain using a pain scale * Have their oral hygiene measured
Trial Details
NCT Number NCT07599202
Lead Sponsor Baskent University
Conditions Maxillary Constriction
Enrollment 48 participants
Start Date 2025-08-07
Primary Completion 2026-07 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-20