Clinical Trial

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

Active, Not Recruiting
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Summary
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 Space Maintenance, 3D Printing, Primary Teeth
Enrollment 13 participants
Start Date 2024-05-01
Primary Completion 2025-08-30 (estimated)
Study Completion 2025-10-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-08