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ACTIVE NOT RECRUITING
NCT07161076
NA

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

Sponsor: British University In Egypt

View on ClinicalTrials.gov

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

DEVICE

3d Printed space maintainer

using Next dent permanent crown resin, a digitally designed space maintainer will be 3d printed to maintain space after extraction

DEVICE

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