Accuracy of 3D Printed Custom-Made Registration Method for Dynamic Navigation Implant Surgery Using Mininavident in the Esthetic Zone: A Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Accuracy of Implant Placement Using 3D Printed Registration Markers
研究概览
简要总结
This clinical trial evaluates the accuracy of a 3D printed custom-made registration method for dynamic navigation implant surgery using the Mininavident system in the esthetic zone of the anterior maxilla. Ten patients with a single missing anterior tooth will undergo CBCT-based planning, intraoral scanning, and guided implant placement using 3D printed registration markers. Postoperative CBCT analysis will measure deviations between planned and placed implants in terms of angular, coronal, and apical positions. The study aims to determine whether 3D printed markers provide clinically acceptable accuracy (<2 mm, <5°) and to assess their feasibility as a reproducible alternative to standard registration methods.
详细描述
Accurate implant positioning is essential for esthetic and functional success, particularly in the anterior maxilla. Dynamic navigation systems (DNS) provide real-time guidance but depend on reliable registration between patient anatomy and virtual planning. Errors may occur with conventional fiducial markers, highlighting the need for more precise methods.
This clinical trial investigates the use of 3D printed custom registration markers with the Mininavident DNS for implant placement in the esthetic zone. Ten patients with a single missing anterior tooth will undergo CBCT-based planning and guided implant placement using the custom markers. Postoperative CBCT scans will be compared with preoperative plans to measure positional and angular deviations.
The primary outcome is the accuracy of implant placement, with deviations expected to remain within clinically acceptable limits (<2 mm, <5°). Secondary outcomes include assessing the feasibility and reproducibility of incorporating 3D printed registration into DNS workflows. Results may validate this approach as a cost-effective, patient-specific solution to enhance precision and predictability in implant dentistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single missing tooth in the anterior maxilla
- •≥12 mm bone height and ≥5.5 mm width
- •D3 bone density
- •Angle's Class I occlusion
- •No systemic contraindications to implant surgery
排除标准
- •Heavy smoking or uncontrolled diabetes
- •Radiation therapy involving the head and neck
- •Parafunctional habits (e.g., bruxism)
- •Class III malocclusion or edge-to-edge bites
研究组 & 干预措施
3D Printed Registration for Dynamic Navigation Surgery
Participants with a single missing anterior maxillary tooth will undergo implant placement using the Mininavident dynamic navigation system with a custom-made, 3D printed registration marker. The marker enables registration of CBCT and intraoral scans for prosthetically driven implant planning and real-time guided surgery.
干预措施: D Printed Custom Registration Marker for Dynamic Navigation (Device)
结局指标
主要结局
Accuracy of Implant Placement Using 3D Printed Registration Markers
时间窗: Within 1 week after implant placement
Accuracy will be assessed by measuring deviations between the planned and actual implant positions using postoperative CBCT superimposed with the preoperative plan.
次要结局
未报告次要终点
研究者
Sherif Aly Sadek
Associate Professor
Cairo University