Clinical Performance of a Novel Implant-supported Fixed Dental Prostheses (iFDP): the Dual-cantilevered Single-implant Bridge (T-bridge)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Implant and prosthetic success
研究概览
简要总结
The study aims to evaluate the clinical performance (implant and prosthetic survival/ success rates) of a novel implant-supported fixed dental prosthesis design: the dual-cantilevered single implant bridge (T-Bridge) made out of monolithic zirconia bonded to a titanium base abutment (Variobase abutments)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 20 years
- •Willingness to sign an informed consent and participate in the study
- •Three missing adjacent teeth in the posterior site.
- •Tooth gap of 21-24 mm.
- •Presence of natural or artificial opposing dentition
- •Sufficient vertical interocclusal space of an implant restoration (7mm)
- •Sufficient ridge height to place an implant of 10mm in length
- •Sufficient ridge width for the placement of a 4.1mm diameter implant. Simultaneous GBR to achieve a width of 6.5mm will be included.
排除标准
- •Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
- •Any disorder that would interfere with wound healing or represent a contraindication for implant surgery, such as but not limited to uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates.
- •Pregnancy or lactation
- •Heavy smoking habit with ≥ 10 cig/d
- •Severe bruxism or clenching habits, presence of oro-facial pain
- •Insufficient ridge width/height for the study implant
研究组 & 干预措施
Test
Dual-cantilevered single implant bridge
干预措施: Dual-cantilevered implant bridge (Device)
Control
3-unit implant fixed dental prosthesis
干预措施: 3-unit iFDP (Device)
结局指标
主要结局
Implant and prosthetic success
时间窗: 10 years
Primary outcome parameter: implant and prosthetic success Implant success and survival rate will be defined according to established criteria (Buser et al. 1991): A surviving implant and/or restoration is defined as are in place at the time of the follow-up.
Implant and prosthetic survival
时间窗: 10 years
Implant success and survival rate will be defined according to established criteria (Buser et al. 1991): A surviving implant and/or restoration is defined as are in place at the time of the follow-up.
次要结局
- Implant and prosthetic complications(10 years)