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OpenTrials
Completed

NCT Number: NCT06744153

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

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.

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty od Medical Sciences University of Kragujevac

Kragujevac, 34000, Serbia

About this study

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.

  • 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).
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Space Maintainer

Procedure

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

Primary outcomes

  1. Clinical Evaluation - Fractures and decementing

    Time frame: 6 months

    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.

Secondary outcomes

  1. Bite Force (Newtone)

    Time frame: 1 Day

    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.

Sponsors and collaborators

Lead sponsor

Rasa Mladenovic

Other

Registry information

Official study title

Innovative Functional Space Maintainers Designed Using CAD/CAM Technology

Acronym: KOS&MET

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 20, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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