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

NCT ID: NCT06744153

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2024-11-30

Brief Summary

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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

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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

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Dental Crowns Orthodontics, Interceptive Orthodontic Appliance

Keywords

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functional space maintainers CAD/CAM 3D printing Milling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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3D Print

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).

Group Type ACTIVE_COMPARATOR

Space Maintainer

Intervention Type PROCEDURE

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

Milling

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)

Group Type ACTIVE_COMPARATOR

Space Maintainer

Intervention Type PROCEDURE

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

Interventions

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Space Maintainer

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rasa Mladenovic

OTHER

Sponsor Role lead

Responsible Party

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Rasa Mladenovic

Assistant professor, Pediatric dentist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty od Medical Sciences University of Kragujevac

Kragujevac, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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Ethics Committee

Identifier Type: OTHER

Identifier Source: secondary_id

01-14789/2022

Identifier Type: -

Identifier Source: org_study_id