NCT06749743

Brief Summary

The goal of this observational study is to evaluate the diagnostic accuracy of different deep learning models in detecting dental caries from intra oral images taken by a professional intra oral camera in children. The main question it aims to answer is: What is the diagnostic accuracy of different deep learning models in detecting dental caries from intra oral images taken by a professional intra oral camera in children compared to the conventional clinical visual examination?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
398

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 4, 2025

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

December 19, 2024

Last Update Submit

February 28, 2025

Conditions

Keywords

artificial intelligencedental cariesdiagnosisintraoral images

Outcome Measures

Primary Outcomes (1)

  • Accuracy Of Dental Caries Detection From Intraoral Images Using Different Artificial Intelligence Models Versus Conventional Visual Examination Among A Group Of Children: A Diagnostic Accuracy Study

    Diagnostic accuracy of index tests will be determined, including sensitivity, specificity, overall accuracy, positive and negative predictive values and ROC curve analysis.

    one year

Study Arms (2)

training group

images used to train the AI models on detection of dental caries from intraoral images.

Diagnostic Test: FASTER RCNN

test group

images used to test the accuracy of the AI models in diagnosis of dental caries from intraoral images.

Diagnostic Test: FASTER RCNN

Interventions

FASTER RCNNDIAGNOSTIC_TEST

train artificial intelligence models ( FASTER RCNN, YOLOY ) to detect dental caries , then test their accuracy

Also known as: YOLO
test grouptraining group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Any child with at least one decayed tooth present at the time of recruitment at the Pediatric dental department diagnostic center, Faculty of Dentistry, Cairo University.

You may qualify if:

  • Child dentition having at least one decayed tooth.

You may not qualify if:

  • Child dentition with developmental enamel defects.
  • Children with any systemic medical condition.
  • Parent / child refuse to participate in the study.
  • Uncooperative child.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, Giza Governorate, Egypt

Location

MeSH Terms

Conditions

Dental CariesDisease

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 19, 2024

First Posted

December 27, 2024

Study Start

April 30, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

March 4, 2025

Record last verified: 2024-12

Locations