DRKS00031320招募中不适用
Clinical Investigation of single-tooth implants and retained crowns made from additive manufactured hybrid composites for permanent replacement of missing posterior teeth. - RSX+AM-SIC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 26 Years 至 70 Years(—)
- 性别
- All
入选标准
- •Permanent residence in max. 50km vicinity; foreseeable for the next 2 years.
- •Need for fixed prosthetics in one or both jaws:
- •At least one interdental gap or free-end gap in the posterior region with space available and need for
- •- One or two single tooth implants with a fixed crown.
- •2 implants per jaw
- •2 implants per patient
- •Good oral hygiene: PI <50
- •Willingness to participate on a participation basis after deduction of statutory health insurance subsidies of
- •approx. 500 EUR for 1 implant
- •resp.800 EUR for 2 implants
- •incl. crown restoration.
排除标准
- •Tobacco consumption >10 cigarettes per day
- •Diabetes with HbA1c = 7.0
- •Limited legal capacity, current pregnancy
- •Acute or refractory chronic periodontitis or presence of peri-implantitis.
- •Large-volume bone defect requiring two-stage augmentation specifically:
- •- Lack of bone supply of vertically < 11 mm to the anatom. structure and oro-vestibular width <6 mm as well as sagittal width <6 mm
- •- Exceeding the implant-to-crown ratio of 1:2.5
- •Signs of dysfunction/bruxism (DC/TMD criteria) or recurrent orofacial pain, traumatic occlusion in the sense of severe abrasion of the occlusal surfaces or ubiquitous wedge-shaped lesions.
- •Need for removable dentures in the same jaw.
- •Severe limitations of the general condition as oral chir. Risk factors esp.
- •- Need for endocarditis prophylaxis
- •- Tumour disease of the oral cavity
- •- Radiotherapy in the head and/or neck region
- •- Taking medicines that influence bone growth (oral bisphosphonates, monoclonal antibodies against bone metabolism (e.g. denosumab))
- •Multi-allergic patients, unstable CHD, neurological impairments of motor function and cognition)
- •Infectious disease(s), especially relevant titres of hepatitis C virus, HIV, tuberculosis, H1N1, EHEC.
- •Known psychotic or severe affective disorders with regular inpatient treatment.
研究者
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