Evaluation of Immediate Implant Placement Accuracy Using a Dynamic Navigation System. "Randomized Clinical Trial"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Coronal deviation (mm) Apical deviation (mm)
研究概览
简要总结
This clinical study aims to evaluate implant deviation during immediate implant placement using dynamic navigation. By utilizing implant planning software, two CBCT scans (preoperative and postoperative) will be superimposed to assess the accuracy of dynamic navigation in immediate implant placement, which is considered a more complex procedure compared to delayed implant placement
详细描述
First, a fiducial marker will be placed in the patient's mouth, followed by a CBCT scan with the marker in position. The implant will then be virtually planned using implant planning software. Using the MiniNaviDent system and the fiducial marker, the implant will be placed. After placement, a postoperative CBCT scan will be obtained. The postoperative scan will be superimposed onto the preoperative scan to measure implant deviation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients at least 21 years old.
- •Systemically healthy patients with no effect on the surgery.
- •At least one hopeless maxillary or mandibular tooth to be restored using an implant.
- •At least six residual teeth in the affected jaw.
排除标准
- •A medical condition or medication that would impair bone healing.
- •Poor oral hygiene
- •Alcohol users.
- •Smoking more than 10 cigarettes per day.
- •History of head and neck radiotherapy.
- •Pregnant females.
- •Uncontrolled hypertensive or diabetic patients.
研究组 & 干预措施
Dynamic navigation-guided implant placement
Dental implant osteotomy preparation and implant insertion performed using a dynamic navigation system to guide implant placement in real time according to the digital plan (CBCT-based planning with intraoperative navigation guidance)
干预措施: Dynamic navigation system-assisted dental implant placement (Device)
Static guided implant placement
Implant placement performed using a patient-specific CAD/CAM static surgical guide fabricated from the digital plan.
干预措施: CAD/CAM static surgical guide-assisted dental implant placement (Device)
结局指标
主要结局
Coronal deviation (mm) Apical deviation (mm)
时间窗: Pre-op CBCT and post-op CBCT within 7 days after surgery
Implant deviation was defined as the discrepancy between the planned implant position (as established in the preoperative planning software) and the actual implant position placed using dynamic navigation and a static surgical guide. To quantify this deviation, the postoperative CBCT was superimposed (registered) onto the preoperative planned CBCT, and the resulting spatial differences between the planned and placed implants were measured and reported in millimeters (mm)
Angular deviation (degrees)
时间窗: Pre-op CBCT and post-op CBCT within 7 days after surgery
Implant deviation was defined as the discrepancy between the planned implant position (as established in the preoperative planning software) and the actual implant position placed using dynamic navigation and a static surgical guide. To quantify this deviation, the postoperative CBCT was superimposed (registered) onto the preoperative planned CBCT, and the resulting spatial differences between the planned and placed implants were measured and reported in and the angular deviation in degrees was measured.
次要结局
- Total surgical time (minutes)(Intraoperative (day of surgery))