NCT06744153

Clinical Outcomes of Functional Space Maintainers Designed Using CAD/CAM Technology in Early Loss of the First Primary Molar

Innovative Functional Space Maintainers Designed Using CAD/CAM Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Rasa Mladenovic · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

As passive fixed space maintainers do not replace the lost tooth and therefore do not provide a chewing function, this study aims to evaluate the efficiency of an innovative solution for maintaining space after the premature extraction of first primary molars using functional space maintainers based on CAD/CAM technology.

Detailed description

The innovative design of a functional space maintainer named KOS\&MET (Key Orthodontic System and Materials Enhanced Therapy) was created using 3Shape Dental Designer (3Shape A/S, Copenhagen, Denmark). The functional maintainer features an intraoral window for monitoring the eruption of the successor tooth. In addition to its role in maintaining space, the maintainer is designed to restore bilateral chewing function. In addition to the loop encircling the second primary molar, the space maintainer includes a crown for the missing first primary molar. To achieve optimal anatomical details, we applied a mirror model of the molar from the contrary side. Space maintainers were fabricated using CAD/CAM technology in two ways: 3D printing and milling. 1. 3D Print (Metal) - Additive Method: In this group, the functional space maintainer was fabricated from a metal alloy (Co 69%, Cr 25%, W 9.5%, Mo 3.5%, Si 1%, Scheftner, Germany) using a 3D printer (MySint100 Dual Laser, Italy). 2. Milling (Composite) - Subtractive Method: A dental milling machine (Wieland Zenotec Select Hybrid, Germany) was used to fabricate functional space maintainers from a polymer composite material (breCAM.HIPC, Bredent, Germany).

Conditions

• Dental Crowns
• Orthodontics, Interceptive
• Orthodontic Appliance

Interventions

Type	Name	Description
PROCEDURE	Space Maintainer	Fabrication of KOS\&MET functional space maintainer and its cementation.

Timeline

• Start date: 2022-12-15
• Primary completion: 2024-08-20
• Completion: 2024-11-30
• First posted: 2024-12-20
• Last updated: 2024-12-27

Locations

1 site across 1 country: Serbia