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

NCT06276959 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-04-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • West China College of Stomatology

    lead OTHER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-03-01
Completion
2025-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06276959 on ClinicalTrials.gov