Post Market Clinical Follow up Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CeraRoot SL
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Number of Implants That Survived
研究概览
简要总结
The main objective is to evaluate the success / failure rate of CeraRoot ceramic implants (one piece) during three year follow up.
详细描述
Traditionally the material of choice for dental implants has been titanium. The success of such material has been unquestionable for the last decades. However a number of issues arise lately regarding the biocompatibility or cytotoxicity or allergies regarding the degradation or oxidation particles within the bone or gum. Esthetics has been a concern as well specially in patients with thin biotype where the metal may produce a grayish look of the mucosa. For this reason the dental community and patients have raised much interest in ceramic dental implants as a tooth colored and metal free alternative for dental implants.
Since 2006 CeraRoot ceramic implants have been available in the market.
The reason for designing this PMCF is to evaluate the long term success of CeraRoot ceramic implants
To achieve those objectives an observational study of patients that have received such implant is designed, using marginal bone loss as a primary response variable. It is estimated that a sample size 200 patients over the 3 year period is needed to achieve relevant data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients that have received the studied ceramic implant after 27 August
- •Patients of CeraRoot Clinic (Barcelona)
- •Single or multiple missing or hopeless teeth
排除标准
- •The patient is taking medications or having treatments which have an effect on healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
- •Untreated periodontal conditions
结局指标
主要结局
Number of Implants That Survived
时间窗: Baseline to 3 years
Implant without pain, without mobility and in function.
次要结局
- Number of Implants With Surgical Complications (SC)(Baseline to 7 days)
- Number of Implants With Before Loading Implants Complications (BLIC)(7 days post operative to delivery of prosthesis)
- Number of Implants With After Loading Implants Complications (ALIC)(From delivery of prosthesis to two years later.)
- Number of Units With Prosthetic Complications (PC)(Baseline to 3 years)