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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Tooth Loss

Treatments: Other: 3D printed space maintainer; Other: Conventional space maintainer

Study type: Interventional

Funder types: Other

Identifiers

NCT06750068

16111992ayaalaaabdelazizelsaye

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Conventional band and loop space maintainer

Active Comparator group

Description:

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).

Treatment:

Other: Conventional space maintainer

3D printed space maintainer

Experimental group

Description:

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).

Treatment:

Other: 3D printed space maintainer