NCT04769934Unknown不适用
Impact of Implant Insertion Torque on Peri-implant Bone Level.
University of Geneva, Switzerland1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2018年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- radiographic marginal bone level changes around the implant platform
研究概览
简要总结
Observational study with one single arm. The purpose of this study was to evaluate the impact of the insertion torque and of the implant stability on the marginal bone level changes for dental implants placed into healed ridges.
详细描述
The primary outcome would be to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.
The secondary outcomes would be:
- To evaluate the Implant Stability Quotient (ISQ) changes according to the measurements performed with the instrument Penguin RFA
- To evaluate the implant and prosthetic failure rate as well as the implant and prosthetic complication rates
- The patient satisfaction related to the implant treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •All partially edentulous patients requiring simple Implant placement,
- •being at least 18-year-old and able to sign an informed consent,
- •The patients that will be enrolled must have a bone quantity that allows the placement of regular implants according to the radiographic evaluations (pre-operative radiographic examination).
排除标准
- •Heavy smokers (more than 10 cigarettes/day).
- •Immunosuppressed or immunocompromised patients
- •Uncontrolled diabetes
- •Active periodontal disease
- •Patients with a full mouth marginal bleeding score higher than 20%
- •Addiction to alcohol or drugs
- •Psychiatric problems
- •Severe caries, periapical lesions, acute infection (abscess)
- •Immediate post-extractive implants (at least 2 months after extraction have to elapse)
- •Patients unable to commit to 3-year follow-up.
- •Patients treated or under treatment with intravenous amino- bisphosphonates.
- •Patients participating to other studies, if the present protocol could not be fully adhered to.
结局指标
主要结局
radiographic marginal bone level changes around the implant platform
时间窗: 3 years
the changes (in mm) of the marginal bone level around the implant platform
次要结局
- Implant Stability Quotient (ISQ) changes(3 years)
研究者
Irena Sailer
Prof. Dr. Irena Sailer, Head of the Division
University of Geneva, Switzerland
研究点 (1)
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