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

NCT06744153 | Completed

• 2 other identifiers: 01-14789/2022Ethics Committee
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Crowns; Orthodontics, Interceptive; Orthodontic Appliance

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Bite Force (Newtone)

  1 Day

Study Arms (2)

3D Print

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

Space Maintainer PROCEDURE

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

3D Print; Milling

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Systemic disorders and uncooperative children.

Sponsors & Collaborators

• Rasa Mladenovic: lead

Study Sites (1)

Faculty od Medical Sciences University of Kragujevac

Kragujevac, 34000, Serbia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor, Pediatric dentist

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 20, 2024
• Study Start: December 15, 2022
• Primary Completion: August 20, 2024
• Study Completion: November 30, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)