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

NCT06750068 | Not Yet Recruiting DMC

• 1 other identifier: 16111992ayaalaaabdelazizelsaye
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Survival rate

  Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers

  1 year

Secondary Outcomes (3)

• Gingival health of the abutment

  0,6,12 months

• Plaque accumulation on the abutment tooth

  0,6,12 months

• Patients' satisfaction about the impression technique

  Immediately after the im- pression/scanning

Study Arms (2)

Conventional band and loop space maintainer

ACTIVE COMPARATOR

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).

Other: Conventional space maintainer

3D printed space maintainer

EXPERIMENTAL

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).

Other: 3D printed space maintainer

Interventions

3D printed space maintainer OTHER

Digitally fabricated #d printed space maintainer

3D printed space maintainer

Conventional space maintainer OTHER

Stainless steel space maintains

Conventional band and loop space maintainer

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Central Study Contacts

Aya Alaa Abdelaziz Elsayed, Assistant lecturer

CONTACT

+201090802757; aya.alaa@dentistry.cu.edu.eg

Study Design

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

Model Details: 3D printed band and loop space maintainer Conventions band and loop space maintainer

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 27, 2024
• Study Start: March 20, 2025
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share