Research on Intelligent Diagnosis and Treatment Technologies for Craniomaxillofacial Multi-modal Imaging Based on Deep Learning
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- Diagnostic performance of artificial intelligence models for craniomaxillofacial imaging analysis
研究概览
简要总结
This study aims to develop and evaluate deep learning-based artificial intelligence models for craniomaxillofacial multi-modal imaging analysis and clinical decision support. Approximately 2,000 participants with craniomaxillofacial imaging data and related clinical information will be included. The imaging data may include two-dimensional facial photographs, cone-beam computed tomography images, and three-dimensional facial surface scans.
The study will use artificial intelligence methods to analyze craniofacial images and identify clinically meaningful features related to facial morphology, skeletal or dental classification, anatomical landmarks, regional structures, and craniomaxillofacial abnormalities. The models will be developed for tasks such as image classification, anatomical landmark detection, image segmentation, abnormality recognition, and treatment-related decision support.
The purpose of this study is to improve the accuracy, efficiency, and consistency of image-based assessment in dentistry, orthodontics, and oral and maxillofacial clinical practice. The artificial intelligence models developed in this study are intended to provide objective imaging analysis and decision-support information for health care providers. These models are designed to assist clinicians and will not replace professional diagnosis or individualized treatment planning by qualified clinicians.
This research may benefit patients and families by supporting earlier and more accurate recognition of craniomaxillofacial conditions, improving communication about diagnosis and treatment options, and promoting more personalized oral health care. All clinical images and related information will be handled according to approved research procedures and privacy protection requirements.
详细描述
This study is an imaging-based clinical artificial intelligence study that aims to develop, train, and validate deep learning models for craniomaxillofacial multi-modal imaging analysis and intelligent clinical decision support. Approximately 2,000 participants are planned to be enrolled. All participants will have craniomaxillofacial imaging data and related clinical information obtained during routine dental, orthodontic, oral and maxillofacial, or related clinical care.
The imaging data used in this study may include two-dimensional facial photographs, cone-beam computed tomography images, and three-dimensional facial surface scans. Related clinical data may include demographic information, clinical diagnosis, skeletal or dental classification, cephalometric measurements, treatment-related records, and available expert assessments. This study will focus on developing artificial intelligence models for craniomaxillofacial image classification, anatomical landmark detection, regional segmentation, abnormality recognition, and treatment-related decision support.
Before model development, all imaging data will undergo standardized preprocessing. Preprocessing procedures may include image de-identification, quality assessment, format conversion, image orientation correction, cropping, resolution standardization, grayscale or intensity normalization, spatial registration, and region-of-interest extraction. For two-dimensional images, standardized facial or radiographic regions will be defined according to the specific imaging task. For cone-beam computed tomography and three-dimensional facial surface data, preprocessing may include volumetric reconstruction, surface reconstruction, mesh processing, point-cloud processing, or anatomical structure extraction.
Reference labels will be derived from clinical medical records, clinician diagnosis, and expert manual annotation. For segmentation tasks, anatomical regions or structures will be manually annotated by trained clinicians or calibrated researchers. For landmark detection tasks, predefined anatomical landmarks will be annotated according to standardized craniomaxillofacial measurement protocols. For classification tasks, skeletal pattern, dental relationship, craniomaxillofacial morphology category, or other clinically meaningful classification labels will be determined based on expert assessment. Inter-observer and intra-observer consistency will also be evaluated to ensure the reliability of manual annotations and clinical labels.
The dataset of approximately 2,000 participants will be divided into training, validation, and testing datasets. Seventy percent of the data will be used for model training, 15% for model validation, and 15% for independent testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 70 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with available craniomaxillofacial imaging data obtained during routine dental, orthodontic, oral and maxillofacial, or related clinical care.
- •Participants with at least one eligible imaging modality, including two-dimensional facial photographs, cone-beam computed tomography images, or three-dimensional facial surface scans.
- •Participants with related clinical information available for model development or validation, such as demographic information, clinical diagnosis, skeletal or dental classification, cephalometric measurements, treatment-related records, or expert assessment results.
- •Imaging data of sufficient quality for artificial intelligence-based image analysis, annotation, segmentation, landmark detection, classification, or decision-support model development.
排除标准
- •Participants with incomplete or unavailable key imaging data or clinical information required for the planned analysis.
- •Images with severe artifacts, poor resolution, incorrect orientation, incomplete anatomical coverage, or other quality problems that prevent reliable analysis.
- •Duplicate records or repeated imaging records that cannot be reliably linked to a unique participant.
- •Participants whose data cannot be used according to institutional review board approval, consent requirements, or applicable privacy protection regulations.
研究组 & 干预措施
Craniomaxillofacial Imaging Cohort
Participants with available craniomaxillofacial imaging data and related clinical information obtained during routine dental, orthodontic, oral and maxillofacial clinical care.
结局指标
主要结局
Diagnostic performance of artificial intelligence models for craniomaxillofacial imaging analysis
时间窗: At completion of model validation on the independent testing dataset, expected within 12 months after study initiation
The primary outcome is the diagnostic performance of the developed artificial intelligence models on the independent testing dataset. Performance will be evaluated using accuracy, precision, recall, F1-score, sensitivity, specificity, positive predictive value, negative predictive value, receiver operating characteristic curve analysis, and area under the receiver operating characteristic curve, as appropriate for the specific classification or diagnostic recognition task.
次要结局
未报告次要终点
研究者
Yuxin Guo
Research Assistant Professor
Xi'an Jiaotong University
