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

NCT ID: NCT06428344

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2027-06-01

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group

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

No interventions assigned to this group

Trial group

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fan Yang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KY2024060

Identifier Type: -

Identifier Source: org_study_id