Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dental Caries, Artificial Intellegence, Diagnosis, Machine Learning. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Sensitivity, specificity, and accuracy of caries diagnosis [Time frame: Immediately after the completion of all participant information collection.]
Secondary outcome measures (2)
- Miss rate and false positive rate of caries diagnosis [Time frame: Immediately after the completion of all participant information collection.]
- Accuracy of Caries Severity Level Diagnosis [Time frame: Immediately after the completion of all participant information collection.]
Eligibility criteria
Inclusion criteria
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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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06428344 · KY2024060