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Evaluation of a 3D Printed Space Maintainer Versus the Conventional Band and Loop

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Study completion date changed from estimate of Oct 30, 2025 to Jul 21, 2026 Show 4 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Aug 30, 2025 to Jan 30, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is to evaluate whether a new 3D-printed dental device can effectively maintain space after premature loss of primary teeth in children, compared to the traditional stainless-steel device. It will also assess safety and comfort. The main questions it aims to answer are: 1. What is the clinical success rate of 3D printed space maintainers compared to traditional metal band and loop space maintainers over a 12-month period? 2. How do 3D printed space maintainers compare in maintaining space and preventing rotation of abutment teeth? 3. What are the differences in gingival health outcomes between the two types of space maintainers? Participants (13 children aged 6-9 years) will: Receive both devices in a "split-mouth" design (one on each side of the mouth), totaling 26 treated tooth spaces (13 per group). Attend checkups every 3 months for a year to monitor the devices' performance.
Trial Details
NCT Number NCT07161076
Lead Sponsor British University In Egypt
Collaborators: Suez Canal University
Conditions
(from sponsor)		 Space Maintenance, 3D Printing, Primary Teeth
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov