"A Clinical Trial Investigating the Accuracy of Augmented Reality-Guided Miniscrew Placement in Orthodontics"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Accuracy of screw placement
研究概览
简要总结
This study aims to evaluate the effectiveness and accuracy of using Augmented Reality (AR) technology in the placement of mini-screws (Temporary Anchorage Devices) during orthodontic treatment. By combining CBCT images with digital dental scans and visualizing them using AR, clinicians can place mini-screws more precisely. The study is a pilot clinical trial involving patients at the Faculty of Dentistry, Al-Azhar University - Assiut Branch.
详细描述
This is a pilot clinical trial designed to assess the feasibility and accuracy of augmented reality (AR)-guided mini-screw insertion in orthodontic patients. The study involves the use of CBCT imaging and digital intraoral scanning to create a 3D model of the patient's jaw. This model is then processed and integrated into an AR platform that allows real-time visualization of the ideal screw insertion site.
Participants are selected based on inclusion and exclusion criteria. After obtaining informed consent, CBCT and intraoral scans are performed. The proposed mini-screw location is determined digitally and projected using an AR device (tablet or headset) during the clinical procedure.
After insertion, a follow-up CBCT scan is taken to evaluate the deviation between the planned and actual screw positions (linear and angular deviation). Data on insertion time, patient comfort, and operator satisfaction will also be recorded.
The study is conducted at the Faculty of Dentistry, Al-Azhar University - Assiut Branch, with prior ethical approval obtained from the institutional review board.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking will be implemented as both participants and operators will be aware of the intervention type.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients indicated for orthodontic mini-screw placement as part of their treatment plan.
- •Age between 15 and 40 years.
- •Good general health (ASA I or II).
- •Adequate oral hygiene and healthy periodontal condition.
- •Ability to understand and provide informed consent (or guardian consent for minors).
排除标准
- •1 . Systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- •History of craniofacial trauma, surgery, or congenital anomalies in the maxillofacial region.
- •Ongoing periodontal disease or poor oral hygiene.
- •Pregnancy or lactation.
- •Use of medications influencing bone metabolism (e.g., bisphosphonates, corticosteroids).
- •Allergy to local anesthetics or materials used in the procedure.
结局指标
主要结局
Accuracy of screw placement
时间窗: 1 week post-op
Accuracy will be assessed using CBCT imaging compared to planned position
次要结局
未报告次要终点
研究者
omar hassan abd el azeem
studient of master
Al-Azhar University