Artificial Intellegence Rivals Digital Bitewing in Detect Secondary Caries

October 30, 2024 updated by: Heba Tallah Mohamed Mansour, Cairo University

AI Rivals Traditional Bite Wing Radiography in Detecting Proximal Secondary Caries in A Group of Egyptian Patients at Cairo University, Faculty OF Dentistry Hospital (Diagnostic Accuracy Study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dental caries are chronic diseases that results in the destruction of the hard tooth tissues. It is a multifactorial condition that often goes undiagnosed, especially when it is hidden or in its initial stages. Detecting non-cavitated lesions is crucial for their early management. The standard visual-tactile inspection often fails to identify early lesions on hard-to-reach surfaces, such as proximal areas and beneath restorations. Detecting proximal caries early is crucial for implementing effective treatments and achieving optimal outcomes. A common supplementary method for detecting early lesions on proximal surfaces and assessing their extent is bitewing radiography. The routine diagnostic approach combines clinical examination with radiographic evaluation. To increase the detection rate of proximal secondary caries, experts recommend integrating visual and clinical examinations with bitewing radiography. Intraoral bitewing radiographs can be captured using either film or digital sensors, with preference for digital systems due to their benefits of reduced patient exposure, time savings, image enhancement, and ease of image storage, retrieval, and transmission. Although more sensitive for detecting early lesions than visual-tactile assessments, bitewing evaluations comes with significant variance between examiners and a considerable proportion of false-positive or false-negative detections. Recent literature has explored the use of artificial intelligence (AI), a field of computer science focused on developing machines capable of mimicking human cognitive abilities, as a diagnostic tool for detecting caries lesions using dental (digital radiographic) images. As AI technology advances, an increasing number of studies have examined the diagnostic performance of AI-based models, emphasizing the importance of creating reliable tools like AI to enhance the diagnostic process. Numerous studies have assessed the performance of AI models on diverse types of dental radiographs, with a significant focus on bitewing radiographs (BWR). AI has been used for various applications in oral and dental health, including the detection of dental caries, endodontic treatment and diagnosis, periodontal issues, and the detection of oral lesion pathology. A reference dataset of caries diagnoses from bitewing radiographs by different examiners created this benchmark which serves as a crucial tool for comparing the diagnostic performance of AI models against human examiners, emphasizing the potential improvements in accuracy and reliability that AI can bring to dental diagnostics.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
322

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: baseline
models will detect the presence or absence of secondary caries around restorations
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AI in detect dental caries

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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