Assessment of Digital Technologies for Detection of Dental Caries

April 27, 2026 updated by: University Hospital, Martin

Assessment and Comparison of Diagnostic Technologies for the Detection of Dental Caries in Clinical Practice

This study aims to evaluate and compare different digital diagnostic technologies used for the detection of dental caries in clinical practice. The study focuses on assessing the diagnostic accuracy of various methods, including visual examination and digital diagnostic tools, in identifying dental caries in patients. The results will contribute to improving early detection and diagnostic strategies in dentistry.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Dental caries remains one of the most prevalent oral diseases worldwide. Early and accurate detection is essential for effective treatment and prevention of disease progression. This observational study aims to assess and compare the effectiveness of different diagnostic technologies used in routine dental practice.

Participants undergoing dental examination will be evaluated using conventional diagnostic methods and selected digital diagnostic technologies. The diagnostic performance of each method will be analyzed and compared based on their ability to detect carious lesions.

The study will be conducted in clinical settings, including university hospital and private dental clinic environments. The results are expected to provide insights into the advantages and limitations of modern diagnostic technologies in dentistry and support their appropriate use in clinical practice.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

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 Locations

  • Slovakia
    • Žilina Region
      • Martin, Žilina Region, Slovakia, 03601
        • Recruiting
        • Jessenius Faculty of Medicine
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-65 years
  • Presence of permanent dentition only
  • Presence of primary or secondary carious lesions
  • Presence of all teeth in the lateral segment (teeth 4-7) in both maxilla and mandible
  • Signed informed consent including agreement with photodocumentation, bitewing radiographs, and use of AI-based diagnostic methods (including DIAGNOcam)

Exclusion Criteria:

  • Age under 18 or over 65 years
  • Extensive crown destruction affecting more than two-thirds of the tooth
  • Carious lesions reaching the dental pulp or threatening pulp vitality
  • Inability or refusal to undergo radiographic examination (bitewing radiographs)
  • Teeth with fixed prosthetic restorations in the examined area Refusal to participate or to use AI-based diagnostic methods (including DIAGNOcam)

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single diagnostic arm
All participants undergo diagnostic assessment of dental caries using digital technologies (e.g., intraoral imaging, radiographic methods, and/or AI-based analysis, transillumination Diagnocam), followed by clinical verification through operative intervention (cavity opening).
Diagnostic test: Diagnostic methods for dental caries
Diagnostic assessment of dental caries using digital technologies, including intraoral imaging, radiographic methods, AI based analysis and transillumination (Diagnocam), followed by clinical verification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of technologies for detection of dental caries
Time Frame: Baseline/ Day 1
Assessment of sensitivity and specificity of diagnostic methods (including visual examination, intraoral imaging, radiographic methods (Bitewings), AI -based analysis and transillumination) compared to clinical references standard (cavity opening).
Baseline/ Day 1

Collaborators and Investigators

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

Sponsor

University Hospital, Martin

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 (Actual)

November 30, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 27, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHD-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers. Data will be used solely for the purposes of this study and analyzed using diagnostic technologies, including AI-based methods, in accordance with applicable data protection regulations.

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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