Innovative Functional Space Maintainers Designed Using CAD/CAM Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Clinical Evaluation - Fractures and decementing
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Systemic disorders and uncooperative children.
研究组 & 干预措施
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).
干预措施: Space Maintainer (Procedure)
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)
干预措施: Space Maintainer (Procedure)
结局指标
主要结局
Clinical Evaluation - Fractures and decementing
时间窗: 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.
次要结局
- Bite Force (Newtone)(1 Day)
研究者
Rasa Mladenovic
Assistant professor, Pediatric dentist
University of Kragujevac