An interventional study of Space Maintainer in Dental Crowns, Orthodontics, Interceptive and Orthodontic Appliance, sponsored by Rasa Mladenovic. Completed at 1 site in Serbia. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Rasa Mladenovic · Not applicable, Interventional, and Other
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.
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.
Rasa Mladenovic is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Procedure: Space Maintainer
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)
Procedure: Space Maintainer
Fabrication of KOS\&MET functional space maintainer and its cementation.
Clinical Evaluation - Fractures and decementing
The condition of the abutment teeth and surrounding soft tissues, as well as potential fractures or decementing of the space maintainer, were inspected at 1, 3, and 6 months.
Time frame: 6 months
Bite Force (Newtone)
Maximum Occlusal Bite Force in Newtones: Measured using a specially designed dynamometer (RABiter, Kragujevac, Serbia) directly on the space maintainer, with the contrary side of the jaw used as a control.
Time frame: 1 Day
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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