Accuracy of Computer Guided Implant Surgery With the Use of R2Gate Stereolitographic Template
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Measurements of accuracy after implants placement at coronal and apical level
研究概览
简要总结
The investigators' aim is to evaluate the accuracy of the stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level.
Clinical relevance:
- To identify factors influencing the surgical template imprecision.
- To overcome risk factors for surgical template imprecision.
- To suggest improvements for highly accuracy of the surgical template especially for immediate loading and avoiding the injury of anatomical structures.
详细描述
Initial examination, panoramic radiograph to be performed and impression for stone models to be taken to all enrolled patients. For diagnosis accuracy, impression of the surgical site and the opposite arch is mandatory.
For fully edentulous and extensive edentulous subjects - Class III and IV according to the American College of Prosthodontists - ACP - a visible light cure record bases with occlusal rims will be manufactured for bite registration.
CBCT will be taken with a R2 tray filled with impression material or with record basis in centric relation (CR).
CBCT will be performed using same CT machine with a specific setup and alignment to allow accuracy and reproducibility.
A series of axially sliced image data will be obtained and exported to a personal computer in DICOM (Digital Imaging and Communications in Medicine) format.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •fully or partially edentulous patients,
- •good general healty with no contraindications for implant surgery,
- •acceptance of dental implant treatment,
- •acceptance of at least 2 CBCT (one at treatment planning and one after surgery)
排除标准
- •limited bone volume with stadial bone graft requirement,
- •limited mouth opening (imposible to use the surgical stent),
- •parkinson desease (imposible to perform an accurate CBCT)
结局指标
主要结局
Measurements of accuracy after implants placement at coronal and apical level
时间窗: average 10 days
Measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal, oral, mesial and distal.
次要结局
未报告次要终点
研究者
Corina Marilena Cristache
Dr Corina Marilena Cristache, DMD, PhD, senior lecturer
Concordia Dent Srl