Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study

NCT06428344 | Not Yet Recruiting

• 1 other identifier: KY2024060
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries; Artificial Intellegence; Diagnosis; Machine Learning

Keywords

Dental Caries; AI Diagnosis

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity, and accuracy of caries diagnosis

  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.

  Immediately after the completion of all participant information collection.

Secondary Outcomes (2)

• Miss rate and false positive rate of caries diagnosis

  Immediately after the completion of all participant information collection.

• Accuracy of Caries Severity Level Diagnosis

  Immediately after the completion of all participant information collection.

Study Arms (2)

Control group

Dentist specializing in endodontics with over five years of experience independently reviewed the participants' oral panoramic radiographs in a random order.

Trial group

The diagnoses of caries on oral panoramic radiographs were made with the assistance of an artificial intelligence-aided oral panoramic diagnostic system.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

MeSH Terms

Conditions

Dental Caries; Disease

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 10, 2024

Record last verified: 2024-07