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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study completion pushed from Sep 2026 to Dec 2026
    • Primary completion date changed from estimate of Jul 2026 to Jul 31, 2026
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
(from sponsor)
Maxillary Constriction
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov