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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

6 years - 9 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

13 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Double masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

British University In Egypt

Study start

May 1, 2024 Actual

Primary completion

Jan 30, 2026 Actual

Study completion

Jul 21, 2026 Actual

First posted

Sep 8, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.