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NCT Number: NCT07161076

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Space Maintenance 3D Printing Primary Teeth

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The British University in Egypt , Pediatric Dentistry Clinic

El Shorouk, Cairo Governorate, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Clinical Success Rate of Space Maintainers

    Time frame: 12 months

    Percentage of space maintainers remaining functional without failure

    Unit of Measure: Percentage of participants

  2. Gingival health index

    Time frame: 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

  1. Wong-Baker FACES Pain Rating Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Collaborators

  • Suez Canal University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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