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

NCT07161076 | Active Not Recruiting DMC

• 1 other identifier: 648/2023
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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. 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. 2.How do 3D printed space maintainers compare in maintaining space and preventing rotation of abutment teeth?
3. 3.What are the differences in gingival health outcomes between the two types of space maintainers?

Conditions

Space Maintenance; 3D Printing; Primary Teeth

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Clinical Success Rate of Space Maintainers

  Percentage of space maintainers remaining functional without failure Unit of Measure: Percentage of participants

  12 months

• Gingival health index

  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

  at 3-month follow-up, 6 months follow-up , and 1 year follow-up

Secondary Outcomes (1)

• Wong-Baker FACES Pain Rating Scale

  immediately after cementation,at 3-month follow-up

Study Arms (2)

Metal Band and loop

ACTIVE COMPARATOR

Classic Stainless-steel Band and Loop , Control group

Device: stainless steel band and loop

3d Printed Resin band and loop

EXPERIMENTAL

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

Device: 3d Printed space maintainer

Interventions

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

3d Printed Resin band and loop

stainless steel band and loop DEVICE

lab fabricated metal band and loop

Metal Band and loop

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Apparently healthy children.
• Children of both genders aged 6-9 years old.
• Guardians agree to join the study and sign the informed consent.
• Recent premature loss of primary first molars or having primary first molars indicated for extraction on both sides.
• Sound buccal and lingual surfaces of abutment teeth (primary second molar and primary canine).
• Good oral hygiene.
• Absence of radiographic periapical pathology related to the abutment teeth.
• Absence of abnormal occlusal conditions such as posterior crossbite, deep bite, and scissor bite.
• All the indications for a band and loop space maintainer are met.

You may not qualify if:

• The patient is not able to attend regular follow-up visits.
• Allergic condition to any of the used materials.

Sponsors & Collaborators

• British University In Egypt: lead
• Suez Canal University: collaborator

Study Sites (1)

The British University in Egypt , Pediatric Dentistry Clinic

El Shorouk, Cairo Governorate, Egypt

Location

Study Officials

• Omar A Hodhod

  The British University in Egypt , Suez canal university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of pediatric dentistry

Model Details: Split Mouth

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: September 8, 2025
• Study Start: May 1, 2024
• Primary Completion: August 30, 2025
• Study Completion: October 30, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)