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Development and Clinical Evaluation of an Artificial Intelligence-Based Visual System for Precise Caries Assessment in Primary Molars of Preschool Children-diagnostic test

Development and Clinical Evaluation of an Artificial Intelligence-Based Visual System for Precise Caries Assessment in Primary Molars of Preschool Children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105294
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Dental caries

Interventions

Gold Standard:Evaluation results of attending physicians or above with over 5 years of oral clinical practice experience.
Index test:The diagnostic results of the intelligent auxiliary diagnostic system.

Sponsors

Shenzhen Maternity and Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.Children aged 3 - 6. 2.Children with dental caries or indications for pit and fissure sealants. 3.Children without severe systemic diseases, who can participate in relevant research examinations and treatments. 4.Guardians can skillfully use smartphones and WeChat. 5.Guardians sign the informed consent form, agreeing to their child's participation in the study.

Exclusion criteria

Exclusion criteria: 1.Children who have previously been exposed to an AI oral management tool or oral intervention before the start of the study. 2.Children whose first primary molars have not erupted or cannot be detected due to other reasons. 3.Children who are allergic to relevant oral medical devices. 4.Children who cannot cooperate with the study requirements or whose guardians are unwilling to cooperate. 5.Children with severe dental problems requiring urgent treatment.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;false positive rate;false negative rate;agreement rate;

Countries

China

Contacts

Public ContactPing Wen

Shenzhen Maternity and Child Healthcare Hospital

351968312@qq.com+86 138 2889 9883

Outcome results

None listed

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