MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Deviation from planning
研究概览
简要总结
The aim of the present study is to assess the accuracy of MGUIDE MORE System (MGS), consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template by evaluating the difference between planned and actual implant positions on pre- and post-operative CBCTs.
详细描述
Patients, attending the Department of Periodontology at the Rambam School of Graduate Dentistry, who are scheduled for implant therapy, will be screened for the study. Patients will be referred for CBCT of the upper/lower jaw as appropriate. DICOM data of the patient will be uploaded to MGUIDE software and used for diagnosis and treatment planning of the case. Surgery will be performed using MGUIDE MORE template and MGUIDE MORE surgical kit. Pre-operative and post-operative CBCT will be used for assessment of the difference between planned and actual implant positions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Signed and dated inform consent form.
- •Age between 18+.
- •Patient expresses his wish to restore the missing tooth/teeth with dental implants.
- •Patient is examined and found suitable for implant therapy
- •Patient can open mouth sufficiently for preparation and placement of dental implants using the contra-angle handpiece and drills.
- •CBCT is required for proper diagnosis and treatment planning.
排除标准
- 未提供
研究组 & 干预措施
MGUIDE assisted implant placement
Implant placement, using MGUIDE MORE system for implant planning and placement
干预措施: MGUIDE MORE (Device)
结局指标
主要结局
Deviation from planning
时间窗: 0-14 days after implant placement
To assess shoulder and apex deviations in milimeters between planned and actual implant position and to assess angular deviation in degrees, of actual implant position vs. planned implant position
次要结局
未报告次要终点