A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implanting 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
- 102
- 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 evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design 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 similar but non-lateralized Osseotite Certain implants.
详细描述
This is a prospective, randomized-controlled study where patients with qualifying partial edentulism received a short fixed bridge restoration. Each implant site was randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants were placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment continued until 10 patients (approximately 30 implants) were treated 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 dental condition specifically: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are 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 visit
排除标准
- •patients with active infection or severe inflammation in the areas intended for the implants
- •patients with more than 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
- •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
Osseotite Certain
Dental implant without the lateralized design
干预措施: Osseotite Certain (Device)
Osseotite Certain Prevail
Dental implant with lateralized design
干预措施: Osseotite Certain Prevail (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(4 years)