Skip to content

Clinical Performance Evaluation for Dental Cone Beam Computed Tomography X-ray System

Clinical Performance Evaluation for Dental Cone Beam Computed Tomography X-ray System

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098064
Enrollment
Unknown
Registered
2025-03-03
Start date
2025-03-03
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Oral and Maxillofacial Diseases

Interventions

Gold Standard:Computed Tomography scan, CT
Index test:The CBCT device is used for scanning to obtain subjects’ images. After obtaining the images, professional radiologists evaluate the image quality.

Sponsors

Jiangsu Shengze Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age >= 3 years, any gender; (2) Patients requiring oral CBCT examination, including but not limited to: alveolar bone defects, tooth loss, supernumerary teeth, impacted teeth, temporomandibular joint diseases, etc. (3) The subject and/or guardian agrees to participate in this investigation and signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Women who are pregnant or breastfeeding, or plan to conceive within 6 months (both men and women); (2) Those with metal implants in the area which to be scanned; (3) Those with mental disorders who are unable to understand the informed consent form; (4) Those deemed unsuitable for participation in the clinical study by the researchers, such as those currently participating in other drug or device.

Design outcomes

Primary

MeasureTime frame
Image Quality;Accuracy;Sensitivity;Specificity;

Secondary

MeasureTime frame
Device Performance;

Countries

China

Contacts

Public ContactHailang Yan

Jiangsu Shengze Hospital

164714565@qq.com+86 135 8427 2062

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026