A Study on the Fit and Behaviour of Computer-aided Design and Rapid Prototyping Fabrication of Removable Partial Dentures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- fit of framework
研究概览
简要总结
In the clinical trial, the Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) fabricated removable partial dentures (RPD's) are evaluated on casts and clinically compared with a traditional fabricated RPD for 50 consecutive patients.
During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, ... of both groups of dentures.
详细描述
The classic removable partial denture (RPD) is a denture fabricated in CrCo using the "lost wax" technique. This hand-made way of working makes the final result vulnerable, not always predictable and not reproducible.
Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) techniques have been introduced in dentistry, particularly to fabricate crowns and bridges (fixed partial dentures). There is little research in the field of removable partial framework fabrication. This may be in part be attributed to the lack of suitable dedicated software.
In the technical part of the study, existing software and hardware is adjusted to maximize the automation in the application of computer-aided technologies to surveying of digital casts and pattern design and the subsequent production of sacrificial patterns using removable partial (RP) technologies.
In the clinical trial the CAD/CAM fabricated RPD's are evaluated on casts and clinically and compared with a traditional fabricated RPD for 50 consecutive patients. For every patient, two RPDs are made in the same material (CrCo).The clinical parameters (fit, stability, retention, support, friction) are double blind evaluated by two dentists. At the end of the treatment, the patient can choose one of them.
Both RPDs are fabricated in the same time frame for the fabrication of the "classic" RPD. There are for the patient no extra sessions scheduled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients in need of a classic removable partial denture (RPD)
排除标准
- 未提供
研究组 & 干预措施
CAD/CAM fabricated dentures
group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)
干预措施: CAD/CAM fabricated RPD's (Device)
traditional fabricated dentures
group receiving traditional fabricated dentures (double blind)
干预措施: traditional fabricated RPD's (Device)
结局指标
主要结局
fit of framework
时间窗: 9 months
After casting "fit of the framework" between two identical reomvable partial dentures (same design, looks, material...) fabricated in a different way.
次要结局
- placement of RPD + control of placement(3 to 5 days)
- re-evaluation of the RPD placement(every 6 months, for 5 years)