Retrospective Reader Study of AI-Assisted Implant Planning Using Cone-Beam Computed Tomography Data in Edentulous Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical acceptability of AI-generated implant plans
研究概览
简要总结
This retrospective observational reader study will evaluate artificial intelligence (AI)-assisted implant planning using anonymized cone-beam computed tomography (CBCT) datasets from patients with complete edentulism or a clinically equivalent edentulous condition. AI-generated implant plans will be compared with expert reference plans created by clinicians using the same CBCT data. The study will assess the clinical acceptability of AI-generated implant plans, geometric agreement with expert plans, anatomical safety, workflow time, and agreement between expert reviewers where applicable. The study uses previously acquired anonymized imaging data and does not involve patient recruitment, treatment allocation, additional imaging, clinical intervention, or prospective follow-up.
详细描述
This study is designed as a retrospective non-randomized comparative reader study. Anonymized CBCT datasets acquired during routine clinical care will be used for implant planning assessment. For each eligible case, expert clinicians will create reference implant plans without access to AI-generated plans. The AI system will generate implant planning outputs from the same CBCT datasets, and expert clinicians will review the AI-generated plans using a standardized assessment approach. The main evaluation will compare AI-generated plans with expert reference plans within the same case. Outcomes will include clinical acceptability of the AI-generated plan, geometric agreement between AI-generated and expert plans, anatomical safety relative to relevant risk structures, time required for expert planning versus AI-plan review and correction, and inter-reader agreement where applicable. The study does not test an autonomous AI decision-making system. The AI workflow is evaluated as a clinical decision-support tool, and all AI-generated plans are subject to expert clinician review. No new imaging examinations, treatment allocation, patient intervention, or prospective clinical outcome assessment will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anonymized CBCT dataset from a patient with complete edentulism or a clinically equivalent edentulous condition requiring implant prosthodontic planning.
- •CBCT imaging acquired during routine clinical care.
- •Sufficient field of view to assess the jaws and relevant anatomical landmarks for implant planning.
- •Image quality sufficient for anatomical assessment, segmentation, and implant planning.
- •Technical suitability of the CBCT dataset for expert reference planning and AI-assisted implant planning.
排除标准
- •Severe motion artifacts or metal artifacts preventing reliable anatomical assessment.
- •Incomplete field of view preventing assessment of the intended implant planning region.
- •Corrupted, incomplete, duplicate, or unreadable DICOM data.
- •Technical limitations preventing expert reference planning or AI-assisted implant planning.
- •Missing data required for assessment of the primary outcome.
研究组 & 干预措施
Retrospective CBCT Planning Cases
Anonymized cone-beam computed tomography (CBCT) cases from patients with complete edentulism or a clinically equivalent edentulous condition who underwent CBCT imaging for implant planning during routine clinical care. Each case will be evaluated using expert reference planning and AI-assisted implant planning with expert review.
干预措施: AI-Assisted Implant Planning Workflow (Other)
结局指标
主要结局
Clinical acceptability of AI-generated implant plans
时间窗: Baseline
Proportion of AI-generated implant plans rated by expert clinicians as accepted without modification, accepted after minor modification, accepted after major modification, or rejected.
次要结局
- Geometric agreement between AI-generated and expert reference implant plans(Baseline)
- Anatomical safety of AI-generated implant plans(Baseline)
- Workflow time for AI-assisted planning review compared with expert planning(Baseline)
- Inter-reader agreement for clinical acceptability ratings(Baseline)