Clinical trial NCT06428344: Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study
Official title: Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dental Caries
Artificial Intellegence
Diagnosis
Machine Learning
Keywords: Dental Caries
AI Diagnosis
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients visiting the all the three centers during the study period with symptoms of caries as their chief complaint.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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Inclusion Criteria:

1. Patients presenting with clinical manifestations of caries as their chief complaint;
2. Age ≥18 and ≤70 years, irrespective of gender;
3. Oral panoramic radiographs showing a complete dentition, specifically with the second molars and all premolars intact in each quadrant;
4. On the oral panoramic radiographs, the number of teeth with restorations or fillings does not exceed one in any quadrant;
5. Oral panoramic radiographs that are clear, easy to interpret, and free from significant artifacts;
6. Participants who voluntarily agree to partake, can comprehend the purpose of the study, and are capable of signing an informed consent form.

Exclusion Criteria:

1. Oral panoramic radiographs that are unclear, with overlapping, blurring, or artifacts present;
2. Insufficient number of teeth available for study;
3. Severe tooth wear or erosion leading to significant alteration in tooth morphology;
4. Presence of supernumerary teeth, microdontia, or missing teeth;
5. Conditions not suitable for oral radiography, such as pregnancy or undergoing radiation therapy for tumors;
6. Limited mouth opening that precludes clinical examination;
7. Neurological disorders, psychiatric illnesses, or psychological impairments;
8. Participation in another clinical trial within the last three months;
9. Any other condition deemed by the researchers as unsuitable for inclusion in the study.

Primary outcomes:
measure: Sensitivity, specificity, and accuracy of caries diagnosis
timeFrame: Immediately after the completion of all participant information collection.
Secondary outcomes:
measure: Miss rate and false positive rate of caries diagnosis
timeFrame: Immediately after the completion of all participant information collection.
measure: Accuracy of Caries Severity Level Diagnosis
timeFrame: Immediately after the completion of all participant information collection.
Other outcomes:
Locations:
Study officials:
References: