Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Survival of the prosthesis
研究概览
简要总结
The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - acrylic resin prosthesis for full-arch rehabilitation of the atrophic maxillae through the All-on-4 concept after five years of follow-up. The main question it aims to answer is:
- What is the survival outcome of the full-arch implant-supported Poly-ether-ether-ketone - acrylic resin prosthesis? The participants already rehabilitated with dental implants will receive a Poly-ether-ehter-ketone prosthesis as a definitive prosthesis.
详细描述
Following the learning generated during a development study with implant supported fixed prostheses using polyetheretherketone (PEEK) material, it is necessary to evaluate the outcome of implant supported fixed prosthetic rehabilitations using PEEK material in a routine scenario, following optimized laboratory and treatment protocol.
The study design will be a prospective single cohort to evaluate the long term outcome of fixed prosthetic implant supported rehabilitations. The cohort will be evaluated at 6 months, 12 months and annually thereafter until 5 years of follow-up. At each follow-up assessments multiple evaluaitons will be performed to assess the overall outcome of the restorations.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients rehabilitated with immediate function implants for complete edentulous arches through the All-on-4 Concept.
- •Patients in need of definitive implant-supported restorations.
- •Written informed consent from each patient to participate in the study.
排除标准
- •Hindrance to provide written informed consent. (A patient cannot participate if no written consent is given)
结局指标
主要结局
Survival of the prosthesis
时间窗: 5 years
Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
次要结局
- Overall classification from KOL(5 years)
- Manufacture issues(5 years)
- Speech(5 years)
- Survival of the implants(5 years)
- Overall chewing feeling(5 years)
- Oral Health Impact Profile OHIP-14(5 years)
- Veneer adhesion(5 years)
- Incidence of mechanical complications(5 years)
- Denture staining(5 years)
- In mouth comfort(5 years)
- Hygiene around the implants(5 years)
- Incidence of biological complications(5 years)
- Handling of material compared to metal(5 years)
- Hygiene - how much plaque/calculus adheres to the prosthesis(5 years)
- Marginal bone resorption(5 years)
- Patient tissue reaction(5 years)
- Framework integrity(5 years)
- Fit(5 years)
- Aesthetics(5 years)