NCT07404007

Brief Summary

Using a sequence of bitewing radiographs, Artificial intelligence assists in identifying interproximal caries. For the identification of dental caries in bitewing, periapical, and panoramic radiographs, a trained deep learning network will be created This study aimed to investigate the reliability of a novel Artificial Intelligence model based on deep learning in the detection of Proximal Caries using Digital Bitewing Radiographs. (BW).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 15, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

Artificial intelligenceProximal cariesA Diagnostic accuracy Study

Outcome Measures

Primary Outcomes (1)

  • Reliability of the artificial intelligence model in detecting proximal caries on digital bitewing radiographs

    cross-sectional assessment at baseline, with no follow-up period

Study Arms (2)

Group 1 Artificial Intelligence Deep learning that is applied in Diagnosis of the proximal Caries

Diagnostic Test: Artificial Intelligence (AI): Deep learning that is applied in Diagnosis of the proximal Caries

Group 2 : Digital Bitewing manually annotated by human experts

Diagnostic Test: Manual annotation of Digital Bitewing Radiograph by human experts

Interventions

Digital bitewing radiographs were manually annotated by calibrated human experts to identify the presence and location of proximal caries. Annotations were performed using standardized diagnostic criteria and dedicated imaging software to mark suspected lesions. These expert markings served as the reference standard for comparison with the artificial intelligence outputs. Inter-examiner agreement was assessed, and disagreements were resolved by consensus.

Group 2 : Digital Bitewing manually annotated by human experts

Artificial intelligence was used as a deep-learning diagnostic tool to detect proximal caries on digital bitewing radiographs. The system analyzed images and generated probability scores and visual markers for suspected lesions. Its performance was compared with expert examiner diagnoses as the reference standard. AI results were used for evaluation only and did not influence patient treatment decisions.

Group 1 Artificial Intelligence Deep learning that is applied in Diagnosis of the proximal Caries

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending the Faculty dental out patient clinic who required bitewing radiographic examination for routine diagnosis or treatment planning.

You may qualify if:

  • Patients having all Permanent premolars and molars (maximum one tooth missing on each side)

You may not qualify if:

  • Dental Anomalies →Amelogenesis Imperfecta, Dentinogenesis Imperfecta, taurodontism 2- Severe crowding which prevent visualization of teeth Contacts 3-Orthodontic wires bonded to Enamel of the tooth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11331, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Conservative dentistry department

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

January 15, 2023

Primary Completion

September 15, 2025

Study Completion

December 1, 2025

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations