NCT06276959

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

Comparison of Near-infrared Imaging With Cone Beam Computed Tomography for Proximal Caries Detection in Permanent Dentition: An in Vivo Study.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: West China College of Stomatology · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	intraoral scanning	The patients underwent intraoral scanning using an iTero Element 5D imaging system (Align Technology, San Jose, CA, USA). This imaging system uses near-infrared light with a wavelength of 850 nm and provides multiple layers of data in a single scan, including a three-dimensional (3D) model, two-dimensional (2D) color images, and NIRI mapped to the 3D model
DIAGNOSTIC_TEST	clinical oral examination	Under illumination in the dental unit, a UVE of the proximal surfaces of the patient's entire dentition was conducted by clinicians using a mouth mirror, dental probe, and an air-water syringe. Visual and tactile methods were performed according to the guidelines of the American Dental Association. Clinicians assessed the soundness of the proximal surfaces based on the presence of discoloration, surface alterations, or cavitation.
DIAGNOSTIC_TEST	cone-beam computed tomography	All enrolled patients underwent CBCT scans because clear aligner treatment required real root/bone visualization features. We would like to clarify that due to the retrospective cross-sectional nature of this study, the patients involved were not subjected to radiation beyond what was initially necessary for their orthodontic treatment.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2024-02-26
• Last updated: 2024-04-12

Locations

1 site across 1 country: China