Evaluation of 3D-printed Space Maintainers Versus Conventional Space Maintainer : a Randomized Clinical Trial

NCT ID: NCT06750068

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-06-01

Brief Summary

This study aims to compare the clinical evaluation and patients' satisfaction of space maintainers produced by digital workflow using the 3D-printing method (3D-SMs) versus conventional band and loop space maintainers (C-SMs) produced by traditional methods.

Conditions

Tooth Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Conventional band and loop space maintainer

Impressions will be taken from the patients with sterilized plastic pedodontic impression trays and alginate under standard conditions by the same researcher. Alginate will be mixed in accordance with the manufacturer's instructions. After the impressions, plaster study casts will be produced and sent to the laboratory. Conventional SMs will be produced by soldering the 0.7-mm bent orthodonic wires (Dentaurum, Germany) onto previously selected prefabricated molar bands. Prefabricated molar bands (Dentaurum, Germany) in the patient's mouth will be chosen by the physician and then sent to the laboratory with the casts.

All SMs will be cemented by the same investigator under standard conditions using a glass-ionomer luting cement (Nova Glass-L, Imicryl, Konya, Turkey).

Group Type: ACTIVE_COMPARATOR

Conventional space maintainer

Intervention Type: OTHER

Stainless steel space maintains

3D printed space maintainer

Patients in this group will be scanned under standard conditions with Medit i500 (Medit Corp. Seoul, South Korea). The scanned data of the patients will be sent to the laboratory via email in Standard Triangle Language (STL) file format.The design of SMs will be carried out on the DentalCAD 2.2 Valletta (Exocad GmbH, Darmstadt, Germany) program to mimic the conventional space maintainer, and the production will be made by the 3D Selective laser melting (SLM Solutions, Germany) method using titanium-based metal powder (Ti64 Gd23; LPW Technology Ltd., Cheshire, UK). The production of 3D-SMs will start in accordance with the C-SM design in many points, such as the fit of the part surrounding the abutment tooth, thickness, and the position of the loop of 3D-SM.

All SMs will be cemented by the same investigator under standard conditions using a glass-ionomer luting cement (Nova Glass-L, Imicryl, Konya, Turkey).

Group Type: EXPERIMENTAL

3D printed space maintainer

Intervention Type: OTHER

Digitally fabricated #d printed space maintainer

Interventions

3D printed space maintainer

Digitally fabricated #d printed space maintainer

Intervention Type: OTHER

Conventional space maintainer

Stainless steel space maintains

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Lower first permanent molar in active state of eruption
• Patient and parent showing cooperation and compliance.
• Medically free children.
• According to space analysis available space is less than or equal to needed space
• Primary molar loss in the last 1 week due to caries, infection, and resorption (to eliminate possible space loss)
• Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines.

Exclusion Criteria

• Children with previous allergies to stainless steel.
• There was less than one year left for the permanent tooth to erupt (to prevent possible abutment toot loss)
• The patient's oral hygiene is not sufficient and has periodontal problems (to accurately assess the periodontal effects)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Alaa Abdelaziz Elsayed

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Aya Alaa Abdelaziz Elsayed, Assistant lecturer

Role: CONTACT

aya.alaa@dentistry.cu.edu.eg

+201090802757

Other Identifiers

16111992ayaalaaabdelazizelsaye

Identifier Type: -

Identifier Source: org_study_id