Dental CariesNCT07560514
Assessment of Digital Technologies for Detection of Dental Caries
A study testing Diagnostic methods for dental caries in people with Dental Caries, run by University Hospital, Martin at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Diagnostic methods for dental caries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSlovakia
- Study dates
- 30 Nov 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
Jessenius Faculty of Medicine
Martin, Žilina Region, 03601
Tomáš Siebert, doc. MUDr., +421905 859 569, tomas.siebert@uniba.sk
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Diagnostic methods for dental caries
- Keywords
- dental caries, caries detection, digital technology, artificial intelligence
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic methods for dental cariesDiagnostic test
Diagnostic assessment of dental caries using digital technologies, including intraoral imaging, radiographic methods, AI based analysis and transillumination (Diagnocam), followed by clinical verification
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Diagnostic methods for dental caries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline/ Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start30 Nov 2025
- Primary completionMay 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560514
- Sponsor's protocol ID
- PHD-2026-01
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Comparison of Diagnostic Technologies for the Detection of Dental Caries in Clinical Practice
- ClinicalTrials.gov ID
- NCT07560514
- Acronym / sponsor ID
- PHD-2026-01
- Conditions
- Dental Caries
- Keywords
- dental caries, caries detection, digital technology, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single diagnostic arm | Experimental | Diagnostic Test: Diagnostic methods for dental cariesAll 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic methods for dental cariesDiagnostic assessment of dental caries using digital technologies, including intraoral imaging, radiographic methods, AI based analysis and transillumination (Diagnocam), followed by clinical verification | Diagnostic test | Single diagnostic arm |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic methods for dental caries in people with Dental Caries, run by University Hospital, Martin at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Augustín, MDDr. (+421903442708, augustin24@uniba.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of technologies for detection of dental caries (time frame: Baseline/ Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.