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Evaluation of a Novel 3D Printed Space Maintainer Versus the Conventional Stainless-Steel Band and Loop: A Finite Element Analysis and In-Vivo Study
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.
Age
6 - 9 years
Sex
ALL
Healthy Volunteers
Yes
The British University in Egypt , Pediatric Dentistry Clinic
El Shorouk, Cairo Governorate, Egypt
Start Date
May 1, 2024
Primary Completion Date
August 30, 2025
Completion Date
October 30, 2025
Last Updated
September 8, 2025
13
ESTIMATED participants
3d Printed space maintainer
DEVICE
stainless steel band and loop
DEVICE
Lead Sponsor
British University In Egypt
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07195201