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NCT Number: NCT07560514

Assessment of Digital Technologies for Detection of Dental Caries

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessenius Faculty of Medicine

Martin, Žilina Region, 03601, Slovakia

Location status: Recruiting

Location contact

Tomáš Siebert, doc. MUDr.

CONTACT

[email protected]

+421905 859 569

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Michal Augustín, MDDr.

CONTACT

[email protected]

+421903442708

Sponsors and collaborators

Lead sponsor

University Hospital, Martin

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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