NCT06458738进行中（未招募）不适用
Clinical Evaluation of a New Printable Denture Base Material: a Prospective Single-arm Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- rate of failures leading to replacement of denture
研究概览
简要总结
This clinical investigation is conducted to prove the long-term clinical performance of a new printable denture base material. The aim of this study is to assess the failure rate, the quality and functionality of the full dentures made with the printable denture base material over an investigational period of 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 84 years
- •informed consent signed and understood by the subject
- •full edentulous patients
- •a digital design of the dentures is already existing.
- •ability to visit the clinic in person until the baseline recall
排除标准
- •patient does not wear the dentures regularly
- •mental health status does not allow reliable feedback
- •patients with a proven allergy to one of the ingredients (methacrylates) of the materials used
- •patients with severe systemic diseases
- •poor oral / denture hygiene
- •pregnancy
研究组 & 干预措施
Printable denture base material
Experimental
干预措施: Printable denture base material (Device)
结局指标
主要结局
rate of failures leading to replacement of denture
时间窗: 5 years
number of dentures
次要结局
- functional (e.g. retention) properties of the dentures(5 years)
- aesthetic (e.g. surface staining) properties of the dentures(5 years)
- biological (e.g. plaque accumulation) properties of the dentures(5 years)
研究者
研究点 (1)
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