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Evaluation of a 3D Printed Space Maintainer Versus the Conventional Band and Loop
Sponsor: British University In Egypt
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.
Official title: Evaluation of a Novel 3D Printed Space Maintainer Versus the Conventional Stainless-Steel Band and Loop: A Finite Element Analysis and In-Vivo Study
Key Details
Gender
All
Age Range
6 Years - 9 Years
Study Type
INTERVENTIONAL
Enrollment
13
Start Date
2024-05-01
Completion Date
2025-10-30
Last Updated
2025-09-08
Healthy Volunteers
Yes
Interventions
3d Printed space maintainer
using Next dent permanent crown resin, a digitally designed space maintainer will be 3d printed to maintain space after extraction
stainless steel band and loop
lab fabricated metal band and loop
Locations (1)
The British University in Egypt , Pediatric Dentistry Clinic
El Shorouk, Cairo Governorate, Egypt