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临床试验/DRKS00031320
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

Poliklinik für Zahnärztliche Prothetik0 个研究点目标入组 50 人开始时间: 2023年4月5日最近更新:
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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