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

NCT07161076 — Not applicable, Completed, 13 participants, British University In Egypt

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07161076
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	13 (Actual)
Sponsor	British University In Egypt (Other); collaborators: Suez Canal University
Conditions	Space Maintenance, 3D Printing, Primary Teeth
Interventions	3d Printed space maintainer, stainless steel band and loop (Device)
Dates	start 2024-05-01, primary completion 2026-01-30, completion 2026-07-21, first posted 2025-09-08, last updated 2026-09-29
Locations	1 site in Egypt

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Metal Band and loop	Active comparator	Device: stainless steel band and loop	Classic Stainless-steel Band and Loop , Control group
3d Printed Resin band and loop	Experimental	Device: 3d Printed space maintainer	3d printed band and loop with the new design , using Permanent Crown resin

3d Printed space maintainer (Device): using Next dent permanent crown resin, a digitally designed space maintainer will be 3d printed to maintain space after extraction
stainless steel band and loop (Device): lab fabricated metal band and loop

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 6 Years to 9 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
The British University in Egypt , Pediatric Dentistry Clinic	El Shorouk, Cairo Governorate	Egypt

+Study documents

Study Protocol, Statistical Analysis Plan, and Informed Consent Form (PDF, 2023-05-16)

+Investigators

Omar A Hodhod, Principal investigator, The British University in Egypt , Suez canal university

My Notes

Public

To Read Reading Read