Initial Fixation of Bisphosphonate-coated Dental Implants
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Vibration frequency ratio
研究概览
简要总结
16 patients will be included. Each patient receives 2 dental implants. One of them is coated with a drug, zoledronate, to improve fixation. Fixation is measured by vibration resonance frequency analysis at insertion and 2, 4, 6 and 8 weeks after insertion.The 2 implants in each patient are compared. We expect to find an early improvement (higher resonance frequency) in the coated implant.
详细描述
The zoledronate is linked to the titanium implant surface via a nanolayer of crosslinked fibrinigen. Resonance frequency is measured with standard clinical equipment (Ostell apparatus).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need for dental implant in upper jaw. CTscan showing at least 6 mm bucco-lingual thickness. Generally healthy
排除标准
- •Drugs or conditions that influence or are thought to influence bone healing, such as bisphosphonates, corticosteroids, other oral pathologies, severe autoimmune diseases, cancer. Osteoporosis is not cause for exclusion.
结局指标
主要结局
Vibration frequency ratio
时间窗: 4 and 6 weeks
Each patients has a study implant and a control implant. Their change vibation frequency from insertion till measurement time point is measured and the ratio between changes for the 2 implants forms the outcome measure. Avarage values for 4 and 6 weeks will be used.
次要结局
- Marginal resorption(8 weeks)
- Vibration: area under the curve(2-8 weeks)
研究者
Per Aspenberg
professor
University Hospital, Linkoeping