Caries ActiveNCT07048444
Surface Caries Feature Study
An observational study of Caries Active and Caries Root, run by 3Shape A/S.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries Active, Caries Root, Caries,Dental
- What is being tested?
- N/A as observational study
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2025to 1 Mar 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- Willing and able to give informed consent for participation in the study
- Male or female, aged 18 years or above
- Patients looking for dental treatment
- Good general health (i.e. absence of any condition that the Principal Investigator evaluates as a risk either to the subject or to the data quality)
- Able (in the Investigator's opinion) and willing to comply with all study requirements.
- Minimum of 15 natural teeth without crowns
- At least one cavitated caries lesion
Who cannot join
- Patients with orthodontic appliances and permanent retainers
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study)
- Patients who are not able or willing to sign the Informed Consent
- Patients who are currently pregnant. A urine pregnancy test will be administered during the study visit for woman who could be pregnant
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Data Collection for a Surface Caries Detection Software
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.
Read the detailed description
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.
- Conditions
- Caries Active, Caries Root, Caries,Dental, Caries; Initial, Caries Assessment
- Being tested
- N/A as observational study
- Medical subject headings
- Root Caries, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A as observational studyOther
N/A as observational study design
| Study group | Role | What they receive |
|---|---|---|
| Caries active patients | Patients with a history of caries Receives: Other: N/A as observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start22 Jul 2025 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries ActiveStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 3Shape A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New York University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048444
- Sponsor's protocol ID
- CIS-004
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for a Surface Caries Detection Software
- ClinicalTrials.gov ID
- NCT07048444
- Acronym / sponsor ID
- CIS-004
- Conditions
- Caries Active, Caries Root, Caries,Dental, Caries; Initial, Caries Assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- 3Shape A/SIndustry (pharma, biotech, devices)
- Collaborators
- New York University
- Study start
- 22 Jul 2025 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 2 Jul 2025 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caries active patients | – | Other: N/A as observational studyPatients with a history of caries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (7 listed)
- Willing and able to give informed consent for participation in the study
- Male or female, aged 18 years or above
- Patients looking for dental treatment
- Good general health (i.e. absence of any condition that the Principal Investigator evaluates as a risk either to the subject or to the data quality)
- Able (in the Investigator's opinion) and willing to comply with all study requirements.
Key exclusion criteria (4 listed)
- Patients with orthodontic appliances and permanent retainers
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study)
- Patients who are not able or willing to sign the Informed Consent
- Patients who are currently pregnant. A urine pregnancy test will be administered during the study visit for woman who could be pregnant
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 |
|---|---|---|
| N/A as observational studyN/A as observational study design | Other | Caries active patients |
Primary outcome
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)
Time frame: Baseline
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
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 2 Jul 2025.
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Dental Caries
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Caries Active and Caries Root, run by 3Shape A/S.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Mariana Bucovsky (212-998-9426, mb10357@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Baseline). 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 2 Jul 2025.