Surface Caries Feature Study

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

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

Sponsor3Shape A/S

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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 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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

N/A as observational study
Other intervention
N/A as observational study design

Treatment groups

88 Participants

are divided into 1 treatment group

Group A: Caries active patients1 intervention

Trial outcomes

Primary outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

3Shape A/S

Lead sponsor

New York University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: