A Short-term Longitudinal Follow-up After C1 Implant Stability Values.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from baseline in implant ISQ value.
研究概览
简要总结
The aim of the study is to describe the changes found in C1 dental implants through their early healing period.
Patients requiring a standard installation of one or two implants in the maxilla, without any need for bone augmentation, will be frequently followed for 90 days. In every meeting the implants' ISQ values (values denoting the implant stability as being measured by a dedicated, commercially available, appliance called 'Osstell').
The implants' measured ISQ values will be used to describe the changes that may be found in the implants' stability through their healing period.
At the end of the study the patients will be referred to their treating doctor for the completion of implants' restoration (i.e. crown).
详细描述
10 Patients requiring standard implant installation in their maxilla will be recruited to the study.
Inclusion criteria:
- Men and women over the age of 18.
- The patient will be willing, and will be available to attend all the follow-up meetings.
- The patient will accept and sign an informed consent form before the beginning of the study.
Exclusion criteria:
- Pregnant women or women who are breast feeding.
- Patient suffering of untreated periodontal disease.
- Patient who smoke more than 10 cigarettes per day.
- Alcohol abuse.
- Patient suffering of either uncontrolled Diabetes, Osteoporosis, rheumatic arthritis, neoplastic or pre-cancerous condition, or any other condition limiting standard implant installation procedure.
- Patient who need some bone augmentation prior.
- Immediate implant placement or 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
- Diagnostic
- 盲法
- None
盲法说明
open label
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
- •Men and women over the age of
- •The patient will be willing, and will be available to attend all the follow-up meetings.
- •The patient will accept and sign an informed consent form before the beginning of the study.
- •Exclusion criteria:
- •Pregnant women or women who are breast feeding.
- •Patient suffering of untreated periodontal disease.
- •Patient who smoke more than 10 cigarettes per day.
- •Alcohol abuse.
- •Patient suffering of either uncontrolled Diabetes, Osteoporosis, rheumatic arthritis, neoplastic or pre-cancerous condition, or any other condition limiting standard implant installation procedure.
- •Patient who need some bone augmentation prior.
- •Immediate implant placement or restorations.
排除标准
- 未提供
研究组 & 干预措施
C1 Implant
Patient having C1 implant installed.
干预措施: C1 Implant (Drug)
结局指标
主要结局
Change from baseline in implant ISQ value.
时间窗: 90 days (at end of the follow-up).
The change in implants' stability values that were measured by an 'Osstell' appliance at the end of the study as compared to their baseline value.
次要结局
- Implant Marginal Bone Loss (MBL).(90 days (At the end of the follow-up).)