An observational study in Caries Active, Caries Root and Caries,Dental, sponsored by 3Shape A/S. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by 3Shape A/S · Observational
Dental caries (dental cavity) is very common and can impact oral health and oral health-related quality of life. Dental caries is when the tooth surfaces break down, and if left untreated, can cause tooth pain. In routine clinical practice, dental professionals typically assess caries lesions by looking at patients' teeth, touching the areas of interest with a dental probe, and running a probe over the teeth to check the buildup of bacteria.
Dentists often use x-rays to help find cavities, and they can also take pictures of the teeth to show what the problem looks like.
New tools called intraoral scanners are becoming more useful for finding cavities. These scanners do not use radiation and do not hurt. Some computer programs that use artificial intelligence (AI) can also help dentists find cavities. AI can study the spots on patients' teeth and help make better, faster decisions. The purpose of this study is to collect data that will be used to develop and test an AI software that can help dentists in the detection of caries.
This is a single-arm, cross-sectional, open single-site clinical investigation using TRIOS 5 and TRIOS 6 intraoral scanners.
After enrolment, the participant will first undergo an intraoral scan. Next, the participant's teeth will be cleaned to remove plaque and debris, ensuring optimal conditions for the caries examination. Dental bitewing radiographs will be taken to assess any potential caries not visible on the scan. A second intraoral scan will be performed on the cleaned teeth. The examiner will then conduct an examination using standardized diagnostic criteria to assess the presence of caries, and will take intraoral photos of the caries lesions.
The AI-based software will provide a digital assessment of caries for comparison with the clinical evaluation. This comparison will be conducted separately from the clinical data collection. The comparison of the AI output to the clinical data will be performed internally at 3Shape headquarters of Holmens Kanal 7, 1060, Copenhagen, Denmark. This test has no impact on the patients in this study.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
Browse Root Caries studies →This is the only study on the registry with 3Shape A/S as lead sponsor.
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Participants, representing a cross-section of the general population of those persons that seek dental treatment, will be recruited according to an age span from 18 years and above
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a history of caries
Other: N/A as observational study
N/A as observational study design
Diagnostic accuracy for surface caries detection software (SCDS) in surface caries detection on visible tooth surfaces compared to clinical visual tactile examination using the International Caries Detection and Assessment System (ICDAS)
Sensitivity of ≥0.68 and specificity of ≥0.83 for SCDS diagnostic accuracy in surface caries detection on visible tooth surfaces compared to clinical visual tactile examination using the ICDAS
Time frame: Baseline
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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