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

Evaluation of a Novel 3D Printed Space Maintainer Versus the Conventional Stainless-Steel Band and Loop: A Finite Element Analysis and In-Vivo Study

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07161076

Enrollment

Registered

2025-09-08

Start date

2024-05-01

Completion date

2025-10-30

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

3D Printing, Primary Teeth, Space Maintenance

Keywords

3d printing, resin 3d printed space maintainer, 3d printed, space maintainer, split mouth

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.

Interventions

DEVICE3d Printed space maintainer

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

DEVICEstainless steel band and loop

lab fabricated metal band and loop

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Split Mouth

Eligibility

Sex/Gender

ALL

Age

6 Years to 9 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026