RecruitingNCT06276959

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.


Sponsor

West China College of Stomatology

Enrollment

120 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

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Interventions

DIAGNOSTIC_TESTintraoral 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_TESTclinical 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_TESTcone-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.


Locations(1)

West China Hospital of Stomatology, Sichuan University

Chengdu, Sichuan, China

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NCT06276959


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