Assessment of Digital Technologies for Detection of Dental Caries

NCT07560514 | Recruiting

• 1 other identifier: PHD-2026-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

dental caries; caries detection; digital technology; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of technologies for detection of dental caries

  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

Study Arms (1)

Single diagnostic arm

EXPERIMENTAL

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

Interventions

Diagnostic methods for dental caries DIAGNOSTIC_TEST

Diagnostic assessment of dental caries using digital technologies, including intraoral imaging, radiographic methods, AI based analysis and transillumination (Diagnocam), followed by clinical verification

Single diagnostic arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Martin: lead

Study Sites (1)

Jessenius Faculty of Medicine

Martin, Žilina Region, 03601, Slovakia

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Michal Augustín, MDDr.

CONTACT

+421903442708; augustin24@uniba.sk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: May 1, 2026
• Study Start: November 30, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)