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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06744153
Acronym
KOS&MET
Enrollment
28
Registered
2024-12-20
Start date
2022-12-15
Completion date
2024-11-30
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Crowns, Orthodontic Appliance, Orthodontics, Interceptive

Keywords

functional space maintainers, CAD/CAM, 3D printing, Milling

Brief 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).

Interventions

Fabrication of KOS&MET functional space maintainer and its cementation.

Sponsors

Rasa Mladenovic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No

Inclusion criteria

* Indication for extraction or premature loss of the first primary molar in the upper or lower jaw. * A prolonged time period from the loss of the primary tooth to the eruption of its successor (with bone tissue present above the successor tooth on the radiograph). * A complete dental arch on the contrary side of the jaw. * Intact or adequately restored vital second primary molars in the region indicated for the placement of a space maintainer.

Exclusion criteria

* Systemic disorders and uncooperative children.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Evaluation - Fractures and decementing6 monthsThe 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.

Secondary

MeasureTime frameDescription
Bite Force (Newtone)1 DayMaximum 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.

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026