A Prospective, Multicenter, Randomized Multicenter Study of Short Implants Used to Obviate the Need for Sinus Augmentation: an Assessment of Clinical Outcomes and Resource Allocation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ZimVie
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Integration Success of Implant
研究概览
简要总结
This prospective randomized study will evaluate the integration success while supporting a prosthesis for short implants placed into maxillary sites having minimal bone height that would otherwise need sinus augmentation. The resources utilized during treatment will be assessed.
Study (null) hypothesis: the overall benefit of using short length implants to avoid sinus augmentation procedures will offset differences in the cumulative implant survival rates observed between treatment groups.
详细描述
In this randomized study, patients needing restorations in the posterior maxilla will be randomly assigned to the short implant group (test) or the standard length and augmentation group (control). All implants will be placed using a two-stage approach with healing abutments placed at three months and temporary prosthesis at four months following implant and/ or sinus augmentation surgery. Time, materials, and efforts associated with treating test and control cases will be documented to allow an assessment of the costs incurred with each approach.
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 with partial edentulism in the posterior maxilla requiring a unilateral implant-supported maxillary prosthesis
- •patients with a residual alveolar floor of the sinus between 4 and 6 mm in height, as assessed on intraoral radiographs, and able to receive at least a 4mm wide implant
- •patients must be physically able to tolerate conventional surgical and restorative procedures
排除标准
- •patients with active infection or severe inflammation in the areas intended for implant placement
- •patients with a > 10 cigarettes per day smoking habit
- •patients with uncontrolled diabetes or metabolic bone disease
- •patient with a history of therapeutic radiation to the head
- •patients who are known to be pregnant
- •patients with para-functional habits with evidence of severe bruxing or clenching
- •patients not able to commit to a 3 year follow-up program
研究组 & 干预措施
Dental implant (Nanotite)
Dental implants of short length placed without sinus lifts
干预措施: Dental Implant (Nanotite) (Device)
Control group
Dental implants of standard length placed simultaneously with sinus augmentation
结局指标
主要结局
Integration Success of Implant
时间窗: 3 years
Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.
次要结局
未报告次要终点