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

Not Applicable

Active, not recruiting

• Conditions: Space Maintenance; 3D Printing; Primary Teeth

• Registration Number: NCT07161076
• Lead Sponsor: British University In Egypt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Study First Submitted: 2025-05-21
• Status Verified: 2025-08
• Primary Completion: 2025-08-30
• Study First Submitted QC: 2025-08-30
• Last Update Submitted: 2025-08-30
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Success Rate of Space Maintainers	12 months	Percentage of space maintainers remaining functional without failure; Unit of Measure: Percentage of participants
Gingival health index	at 3-month follow-up, 6 months follow-up , and 1 year follow-up	measuring Gingival index for both space maintainers to compare the a ability of plaque to attach to both devices. scale 0-3, higher scores indicate worse gingival health

Secondary Outcome Measures

Name	Time	Method
Wong-Baker FACES Pain Rating Scale	immediately after cementation,at 3-month follow-up	Scale Range: 0 (no hurt) to 10 (hurts worst); Interpretation: Higher scores indicate worse pain/lower satisfaction

Trial Locations

Locations (1)

The British University in Egypt , Pediatric Dentistry Clinic; 🇪🇬 El Shorouk, Cairo Governorate, Egypt