Observational Study of Certain Prevail Implant System in Maxillary and Mandibular Regions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ZimVie
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Osseous Integration
研究概览
简要总结
This observational, prospective clinical study evaluates the performance of the Certain Prevail implant system to show potential crestal bone and soft tissue preservation following the crestal bone. It will also evaluate implant performance.
Study (null) hypothesis: The preservation of crestal bone for the Certain Prevail implants will be the same as that for standard non-platform switched implants from contemporaneous studies (historical controls).
详细描述
This is a prospective, observational study of patients with partial or complete edentulism treated with the Certain Prevail dental implants. Restorations will consist of single tooth replacements, short and long fixed bridges, and overdentures and full dentures. All implants are placed using a single stage approach and temporalization occurring after two months of healing (early loading). Each center will strive to enroll a total of 20 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of either sex and any race greater than 18 years of age
- •patients for whom a decision has already been made to use dental implants for treating an existing dental condition specifically:
- •dental implants restored as single tooth replacements, short and long fixed bridges, overdenture, or fixed full denture.
- •a temporary healing abutment will be placed on implant during implant placement surgery (single stage procedure).
- •patients must be physically able to tolerate conventional surgical and restorative procedures
- •patients must agree to be evaluated for each study visit, especially the yearly follow-up visit
排除标准
- •patients with active infection or severe inflammation in the areas intended for implant placement
- •patients with a >10 cigarette per day smoking habit
- •patients with uncontrolled diabetes mellitus
- •patients with metabolic bone disease
- •patients who have had treatment with therapeutic radiation to the head within the past 12 months
- •patients in need of allogenic bone grafting at the site of the intended study implant for augmentation purposes. Grafting for treatment of dehiscence or fenestration must have occurred at least 8 weeks prior to implant placement surgery
- •patients who are pregnant at the screening visit
- •patients with evidence of severe para-functional habits such as bruxing or clenching
- •patients with less than 6 weeks of healing time post tooth extraction at the intended treatment site
结局指标
主要结局
Osseous Integration
时间窗: one year
Osseous Integration
时间窗: 2 years
次要结局
- Crestal Bone Resorption(four years)