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Validation of Oral Panoramic X-Ray Imaging Assisted Diagnosis Software

Validation of Oral Panoramic X-Ray Imaging Assisted Diagnosis Software

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20241218005
Enrollment
400
Registered
2024-12-18
Start date
2025-02-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. What is the sensitivity and specificity of the Oral X-ray Imaging Assisted Diagnosis Software in detecting different stages of caries? 2. How does the AI system&#039

Interventions

In total, a total of 400 subjects will be retrospectively included in this clinical trial, including 300 subjects with caries (100 superficial, 100 intermediate, 100 deep), 100 subjects without caries
Diagnostic

Sponsors

Faculty of Dentistry, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Oral panoramic radiographs of patients aged 18 and above, regardless of gender. 2. Oral panoramic images taken at the Department of Radiology, Faculty of Dentistry, Chulalongkorn University and Department of Radiology, Faculty of Medicine, Chulalongkorn University/King Chulalongkorn Memorial Hospital, Thai Red Cross Society during 2022-2024. 3. Images acquired according to standard institutional protocols, covering a wide range of dental caries. Factors affecting image visibility will be either included or controlled. For example, radiographs from different manufacturers, models, and machines, with varying patient positioning, exposure factors, and image enhancement filters, will be enlisted and standardized. 4. The panoramic images of the oral cavity used for reading are desensitized and do not contain personal sensitive information that can be used to identify natural persons, nor do they contain information that can be used to determine specific institutions. 5. The panoramic image of the oral cavity conforms to the formats of dcm, jpg, png, bmp, and tiff. 6. Oral panoramic image scanning standard, clear image, and the size of a single image file should not exceed 30MB. 7. The oral panorama image is at 8-bit (0-255) grayscale, with an average canary release value between 70 and 180. The canary release standard Deviation should not be lower than 25, with the teeth centered and the mandible fully displayed without artifacts. The image resolution should not be lower than 800*1200 pixels.

Exclusion criteria

Exclusion criteria: 1. Non-diagnostic quality radiographs and sub-standard images, such as overexposed, underexposed, distorted, or blurred images. 2. Images with conditions that obscure the region of interest, such as existing pathology or a history of surgery or physical treatment in the area. 3. Patient oral panoramic images are used in the software development process for Model Training. 4. Full mouth panoramic film with missing teeth. 5. Panoramic images of existing teeth with residual roots in the maxillary/mandibular dentition. 6. All existing teeth in the maxillary/mandibular dentition are panoramic images of crown restoration. 7. The image quality is poor, which obviously affects the doctor's viewing of the panoramic film.

Design outcomes

Primary

MeasureTime frame
Full mouth panoramic film at 12 months after end of the intervention Oral Panoramic X-ray Imaging Assisted Diagnosis Software

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactThantrira Porntaveetus

Faculty of Dentistry, Chulalongkorn University

thantrira.p@chula.ac.th0819999939

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026