A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in Millimeters of Bone Loss Surrounding the Implant Device
研究概览
简要总结
The study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar.
The investigators hypothesize the fully textured implant will result in less peri-implant crestal bone resorption than the implant with a machined collar.
详细描述
Zimmer dental has developed a microtextured tapered screw-vent implant design with a titanium skin that has been grit-blasted with hydroxyapatite particles resulting in an overall roughened surface, which, when compared to an implant with a machined (smooth) collar (narrow band around the top of the device) surface is thought to increase the apposition of osseous tissue integration and to promote epithelial attachment to the implant device.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be a current registered University of Alabama at Birmingham (UAB)dental school patient
- •Existence of one or more missing teeth scheduled to be replaced with dental implants
- •Healthy enough to undergo proposed therapy without compromising existing health
- •Able to consent for their own inclusion
- •Able to read and understand the informed consent form
- •Demonstrated willingness to comply with protocol requirements and timeline
排除标准
- •Any health condition that in the opinion of the investigators may adversely affect bone healing
- •Any medication that in the opinion of the investigators may adversely affect bone healing
- •Any indication of an inability to make autonomous decisions
- •Reported pregnancy at the time of enrollment -
结局指标
主要结局
Change in Millimeters of Bone Loss Surrounding the Implant Device
时间窗: Implant insertion, 12 months post-insertion
Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.
次要结局
- Changes in Peri-implant Gingivitis Score(1 year after placement)
- Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device(1 year after placement)
研究者
Michael Reddy, DMD
Professor
University of Alabama at Birmingham