The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth

West China College of Stomatology

Status: Enrolling

Conditions: Dental Caries

Treatments: Diagnostic Test: clinical oral examination; Diagnostic Test: cone-beam computed tomography; Diagnostic Test: intraoral scanning

Study type: Observational

Funder types: Other

Identifiers

NCT06276959

WCHSIRB-D-2022-430

Details and patient eligibility

About

As a new emerging technology for the diagnosis of dental caries, near-infrared imaging requires further research and validation to determine its effectiveness. This study aims to compare near-infrared imaging with cone-beam computed tomography (CBCT) to validate the efficiency of near-infrared imaging in diagnosing proximal caries using large-scale clinical data through retrospective cross-sectional studies.

Enrollment: 120 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Permanent dentition
• Participants aged 12 and above
• Patients who have undergone iTero Element 5D oral scanning, as well as CBCT imaging, intraoral photography, and clinical oral examination within 1 week
• CBCT or iTero Element 5D oral scanning indicating proximal caries

Exclusion criteria

The following teeth were excluded:

• Third molars
• Teeth with gross loss of tooth structure (cavitated carious lesions extending to the occlusal or buccal/lingual surfaces)
• Teeth with amalgam fillings and their adjacent teeth
• Teeth with crown restorations and their adjacent teeth

Trial design

120 participants in 1 patient group

The population with a potential risk of proximal caries.

Treatment:

Diagnostic Test: cone-beam computed tomography

Diagnostic Test: intraoral scanning

Diagnostic Test: clinical oral examination