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

NCT ID: NCT07161076

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-10-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Metal Band and loop

Classic Stainless-steel Band and Loop , Control group

Group Type: ACTIVE_COMPARATOR

stainless steel band and loop

Intervention Type: DEVICE

lab fabricated metal band and loop

3d Printed Resin band and loop

3d printed band and loop with the new design , using Permanent Crown resin

Group Type: EXPERIMENTAL

3d Printed space maintainer

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

stainless steel band and loop

lab fabricated metal band and loop

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Apparently healthy children.

2. Children of both genders aged 6-9 years old.

3. Guardians agree to join the study and sign the informed consent.

4. Recent premature loss of primary first molars or having primary first molars indicated for extraction on both sides.

5. Sound buccal and lingual surfaces of abutment teeth (primary second molar and primary canine).

6. Good oral hygiene.

7. Absence of radiographic periapical pathology related to the abutment teeth.

8. Absence of abnormal occlusal conditions such as posterior crossbite, deep bite, and scissor bite.

9. All the indications for a band and loop space maintainer are met.

Exclusion Criteria

1. The patient is not able to attend regular follow-up visits.

2. Allergic condition to any of the used materials.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suez Canal University

OTHER

Sponsor Role: collaborator

British University In Egypt

OTHER

Sponsor Role: lead

Responsible Party

Omar hodhod

Assistant lecturer of pediatric dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar A Hodhod

Role: PRINCIPAL_INVESTIGATOR

The British University in Egypt , Suez canal university

Locations

The British University in Egypt , Pediatric Dentistry Clinic

El Shorouk, Cairo Governorate, Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

648/2023

Identifier Type: OTHER

Identifier Source: secondary_id

648/2023

Identifier Type: -

Identifier Source: org_study_id