A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implant in Short-span Fixed Bridge Cases for Preservation of Crestal Bone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ZimVie
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit
研究概览
简要总结
This prospective, randomized study will evaluate the performance of the Osseotite Certain Prevail implant when compared to that of the non-lateralized version of the implant.
Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for a similar but non-lateralized Osseotite Certain implant.
详细描述
This is a prospective, randomized, longitudinal study in which qualified patients with partial edentulism will receive a short-fixed bridge restoration. Each implant site is randomized to receive either the Osseotite Certain Lateralized (test) or the Osseotite Certain Non-lateralized (control). All implants will receive a temporary prosthesis after two months of placement. Enrollment will include up to 20 patients (approximately 60 implants per center) at each participating study center.
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
- None
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 condition specifically: A partially edentulous short-span fixed case of less than 4 implants in the maxilla or mandible; the prosthesis may be anterior, posterior, or transitionally anterior-posterior; no cantilevers allowed but one interior crown may be a pontic
- •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 visits
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 a the site of the intended study implant
- •patients who are pregnant at the screening visit
- •patients with evidence of severe para-functional habits such as bruxing or clenching
- •patients with cantilevers and more than one pontic per bridge
研究组 & 干预措施
Dental implant Osseotite Prevail
Dental implant with lateralized design
干预措施: Dental implant Osseotite Prevail (Device)
Dental implant Osseotite
Dental implant without the lateralized design
干预措施: Dental implant Osseotite (Device)
结局指标
主要结局
Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit
时间窗: 1 year
Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.
次要结局
- Osseous Integration(four years)