Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 主要终点
- Sensitivity, specificity, and accuracy of caries diagnosis
研究概览
简要总结
This clinical trial was designed as a prospective, multicenter, multi-reader multi-case (MRMC), superiority, parallel-controlled study. Participants who met the trial criteria and signed the informed consent form were enrolled. The trial group involved diagnoses of caries on panoramic radiographs using an artificial intelligence-assisted diagnostic system, while the control group involved diagnoses made by dental practitioners specializing in operative dentistry and endodontics with five years of experience, who interpreted oral panoramic radiographs to determine the presence and severity of caries.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Patients presenting with clinical manifestations of caries as their chief complaint;
- •Age ≥18 and ≤70 years, irrespective of gender;
- •Oral panoramic radiographs showing a complete dentition, specifically with the second molars and all premolars intact in each quadrant;
- •On the oral panoramic radiographs, the number of teeth with restorations or fillings does not exceed one in any quadrant;
- •Oral panoramic radiographs that are clear, easy to interpret, and free from significant artifacts;
- •Participants who voluntarily agree to partake, can comprehend the purpose of the study, and are capable of signing an informed consent form.
排除标准
- •Oral panoramic radiographs that are unclear, with overlapping, blurring, or artifacts present;
- •Insufficient number of teeth available for study;
- •Severe tooth wear or erosion leading to significant alteration in tooth morphology;
- •Presence of supernumerary teeth, microdontia, or missing teeth;
- •Conditions not suitable for oral radiography, such as pregnancy or undergoing radiation therapy for tumors;
- •Limited mouth opening that precludes clinical examination;
- •Neurological disorders, psychiatric illnesses, or psychological impairments;
- •Participation in another clinical trial within the last three months;
- •Any other condition deemed by the researchers as unsuitable for inclusion in the study.
结局指标
主要结局
Sensitivity, specificity, and accuracy of caries diagnosis
时间窗: Immediately after the completion of all participant information collection.
Sensitivity: Sensitivity assesses the diagnostic method's ability to identify the disease, that is, how many true cases of caries can be correctly identified among all actual cases of caries. Specificity: Specificity evaluates the diagnostic tool's ability to recognize the absence of disease, meaning how many true non-caries cases can be correctly identified among all actual non-caries cases. Accuracy: Accuracy evaluates the overall correctness of the diagnostic tool in diagnosing the disease.
次要结局
- Accuracy of Caries Severity Level Diagnosis(Immediately after the completion of all participant information collection.)
- Miss rate and false positive rate of caries diagnosis(Immediately after the completion of all participant information collection.)
研究者
Fan Yang
Chief Physician
Zhejiang Provincial People's Hospital