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

NCT07161076 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

  • Space Maintenance
  • 3D Printing
  • Primary Teeth

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

Sponsors & Collaborators

  • Suez Canal University

    collaborator OTHER

  • British University In Egypt

    lead OTHER

Principal Investigators

  • Omar A Hodhod · The British University in Egypt , Suez canal university

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-08-30
Completion
2025-10-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07161076 on ClinicalTrials.gov