Surface Caries Feature Study

NCT07048444 | Not Yet Recruiting FDA Device

• 1 other identifier: CIS-004
• Study Type: observational
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Caries Active; Caries Root; Caries,Dental; Caries; Initial; Caries Assessment

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline

Study Arms (1)

Caries active patients

Patients with a history of caries

Other: N/A as observational study

Interventions

N/A as observational study OTHER

N/A as observational study design

Caries active patients

Eligibility Criteria

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

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 3Shape A/S: lead
• New York University: collaborator

MeSH Terms

Conditions

Root Caries; Dental Caries

Interventions

Observation

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Mariana Bucovsky

CONTACT

212-998-9426; mb10357@nyu.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 22, 2025
• Primary Completion: December 20, 2025
• Study Completion: March 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-07