NCT06667986

Brief Summary

This study uses digital bitewing radiography as a standard for diagnosing proximal secondary caries. Patients will undergo imaging with a parallel technique and fixed settings to ensure high-quality, consistent images. Radiographs are interpreted by experienced dental professionals to maintain diagnostic accuracy. Machine learning models YOLO and Mask-RCNN will analyze these images in three phases: pre-analytical, analytical, and post-analytical. A dataset of 322 labeled images, annotated by experts, is used to train these models. Data augmentation methods enhance model performance, and accuracy is assessed against radiographic results to confirm reliability.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 30, 2024

Last Update Submit

October 30, 2024

Conditions

Keywords

Secondary caries, Artificial intelligence, Digital bitewing radiography, Diagnostic accuracy study.

Outcome Measures

Primary Outcomes (1)

  • two deep learning models, YOLO and Mask-RCNN, will be trained on this dataset to accurately detect and classify images showing signs of secondary caries

    models will detect the presence or absence of secondary caries around restorations

    baseline

Interventions

machine learning model will used to detect secondary caries around restorations by comparing the results with digital bitewing radiography

Eligibility Criteria

Age22 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients attending the Conservative Department at Cairo University Dental Clinic who present with proximal restorations, show no signs or symptoms, demonstrate cooperation, and express interest in participating in the study will be considered eligible. Patients with orthodontic appliances or bridgework that could impact the quality of radiographic imaging will be excluded.

You may qualify if:

  • Adult Patients Aged 22-60 Patient
  • Males or females.
  • Patients have proximal restorations.
  • Co-operative patients who show interest in participating in the study.

You may not qualify if:

  • Patients with orthodontic appliances, or bridge work that might interfere with evaluation
  • Patients with no caries.
  • Systematic disease that may affect participation.
  • Patients not willing to be part of the study or ones who refuse to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Chaves ET, Vinayahalingam S, van Nistelrooij N, Xi T, Romero VHD, Flugge T, Saker H, Kim A, Lima GDS, Loomans B, Huysmans MC, Mendes FM, Cenci MS. Detection of caries around restorations on bitewings using deep learning. J Dent. 2024 Apr;143:104886. doi: 10.1016/j.jdent.2024.104886. Epub 2024 Feb 9.

  • Mohammad-Rahimi H, Motamedian SR, Rohban MH, Krois J, Uribe SE, Mahmoudinia E, Rokhshad R, Nadimi M, Schwendicke F. Deep learning for caries detection: A systematic review. J Dent. 2022 Jul;122:104115. doi: 10.1016/j.jdent.2022.104115. Epub 2022 Mar 30.

  • Mertens S, Krois J, Cantu AG, Arsiwala LT, Schwendicke F. Artificial intelligence for caries detection: Randomized trial. J Dent. 2021 Dec;115:103849. doi: 10.1016/j.jdent.2021.103849. Epub 2021 Oct 14.

  • Chen X, Guo J, Ye J, Zhang M, Liang Y. Detection of Proximal Caries Lesions on Bitewing Radiographs Using Deep Learning Method. Caries Res. 2022;56(5-6):455-463. doi: 10.1159/000527418. Epub 2022 Oct 10.

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Prof. Dr. Heba Hamza, professor

    Professor of Conservative Dentistry Department, Faculty of Dentistry, Cairo University

    STUDY DIRECTOR
  • Dr. Rawda Hisham A. ElAziz, lecturer

    Lecturer of Conservative Dentistry Department, Faculty of Dentistry, Cairo University

    STUDY DIRECTOR
  • Dr. Asmaa Ahmed Elsayed Osman, lecturer

    Lecturer of Information Technology, Faculty of Computers and Artificial Intelligence, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Heba-Tullah mohamed mansour, master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
general Practitioner at Health Administration, Faculty of Pharmacy, Cairo University

Study Record Dates

First Submitted

October 30, 2024

First Posted

October 31, 2024

Study Start

November 15, 2024

Primary Completion

November 15, 2025

Study Completion

February 15, 2026

Last Updated

October 31, 2024

Record last verified: 2024-10