Morphological Characteristics of Anterior Maxillary Anchorage Sites and Application of Dynamic Navigation in Full-Arch Dental Implant Placement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Bone-to-implant contact
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of dynamic navigation in full-arch dental implant placement in patients with complete maxillary edentulism. The main questions it aims to answer are:
- the accuracy of nasopalatine implants, trans-sinus implants, and trans-nasal implants placement in the anterior maxillary bone with dynamic navigation
- the clinical effectiveness of nasopalatine implants, trans-sinus implants, and trans-nasal implants in full-arch rehabilitation
- the correlation between the anatomical features of the nasal cavity and the anterior sinus wall on CBCT images and their influence on nasopalatine implants, trans-sinus implants, and trans-nasal implants position
详细描述
This study aims to explore the anatomical features of the anterior maxillary bone and then apply dynamic navigation technology for full-arch dental implant placement. The primary goal is to assess how dynamic navigation can improve the precision and success of implant placement in patients with complete edentulism or significant bone resorption in the upper jaw.
- Objectives:
- To analyze the anatomical features of the nasopalatine canal and the anterior sinus wall using CBCT imaging to guide full-arch implant placement.
- To evaluate the accuracy of implant surgeries, including the placement of nasopalatine implants, trans-sinus implants, and trans-nasal implants, with the assistance of dynamic navigation systems.
- To assess the clinical effectiveness of nasopalatine implants, trans-sinus implants, and trans-nasal implants in full-arch rehabilitation.
- To investigate the correlation between the anatomical features of the nasal cavity and the anterior sinus wall on CBCT images and their influence on implant placement outcomes.
- Clinical Study:
Study Type: Clinical Trials Study. Study Period: From 2024 to 2027.
Study Locations:
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Good overall health (Class 1 and 2 according to the American Society of Anesthesiologists classification system)
- •Clinical diagnosis of complete edentulism of the upper arch classified as Class IV to VI according to Cawood and Howell
排除标准
- •Systemic or local conditions that may affect surgery, wound healing, or bone integration, such as cardiovascular diseases, diabetes, bone-related diseases, or medication affecting bone metabolism
- •Smoking more than 10 cigarettes per day
- •Presence of acute infections in the planned implant site
- •Limited mouth opening of less than 40mm
研究组 & 干预措施
Full-arch dental implant treatment with dynamic navigation
This study involves placing three types of implants-nasopalatine, trans-sinus, and trans-nasal implants-using dynamic navigation in patients with complete maxillary edentulism and severe bone resorption. The primary goal is to assess the accuracy of implant placement and the clinical effectiveness of these implants for full-arch rehabilitation. Key measurements, such as 3D deviation, lateral and vertical linear deviation, and angular deviation, will be analyzed to compare the actual and planned implant positions. This study aims to evaluate the precision and success of dynamic navigation-assisted implant placement in patients with significant bone loss.
干预措施: Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation (Procedure)
结局指标
主要结局
Bone-to-implant contact
时间窗: From enrollment to the end of surgery (second CBCT)
Radiographs are analyzed to measure the bone level around the implant (mm). Bone-to-implant contact (BIC) is a crucial parameter used to evaluate the success and stability of dental implants.
3D Deviation at Apex
时间窗: From enrollment to the end of surgery (second CBCT)
This measures the 3D deviation at the apex (bottom) of the implant site, which similarly involves assessing the horizontal and vertical position, along with depth, between the planned and actual implant positions at the tip of the implant (mm).
3D Deviation at Coronal
时间窗: From enrollment to the end of surgery (second CBCT)
This measures the three-dimensional (3D) deviation between the planned implant position and the actual implant position at the coronal (top) aspect of the implant site (mm). It involves assessing discrepancies in the X, Y, and Z axes (horizontal, vertical, and depth).
Lateral Linear Deviation
时间窗: From enrollment to the end of surgery (second CBCT)
This measures the horizontal distance (in the X or Y axis) between the planned implant position and the actual position (mm), specifically at the coronal or apical levels, and refers to any shift in the lateral direction.
Vertical Linear Deviation
时间窗: From enrollment to the end of surgery (second CBCT)
This measures the vertical distance between the planned and actual positions of the implant, assessing any deviation in the upward or downward direction along the Z axis (mm).
Angular Deviation
时间窗: From enrollment to the end of surgery (second CBCT)
This measures the angular (°) difference between the planned angle of the implant and the actual angle of the implant at the coronal or apical level. It helps assess how well the implant's rotation and orientation match the planned design.
次要结局
- Implant Survival Rate at 6 months post-surgeryy(From enrollment to the prosthetic stage (6 months post-surgery))
- Stability of Implant(From enrollment to the prosthetic stage (6 months post-surgery))
- Torque value(In the surgery)
研究者
Bui Tan Lam
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City