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.

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Diagnostic test: clinical oral examination; Diagnostic test: cone-beam computed tomography; Diagnostic test: intraoral scanning

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Stomatology, Sichuan University
      • Contact: Zhihe Zhao, Doctor; Phone Number: +86 139 8188 1666; Email: zhzhao@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent orthodontic treatment at the West China School of Stomatology.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

The population with a potential risk of proximal caries.

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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive percent agreement	Using CBCT as the reference test, positive percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.	After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.
negative percent agreement	Using CBCT as the reference test, negative percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.	After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.
overall percent agreement	Using CBCT as the reference test, overall percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.	After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proximal caries positive site diagnosed by CBCT	Diagnosis of of carious proximal tooth surfaces identified through CBCT. Specifically, the cross-sectional view showing the deepest caries involvement was used for International Caries Detection and Assessment System (ICDAS) scoring and was categorized into shallow caries, moderate caries (ICDAS 1-2), and deep caries (ICDAS 3-6).	Immediately following CBCT image interpretation.
Proximal caries positive site diagnosed by near-infrared imaging (NIRI)	Owing to the challenges in applying ICDAS scoring for proximal caries detected using NIRI, the classification was either positive (manifest as bright areas) or negative.	Immediately following NIRI image interpretation.
Proximal caries positive site diagnosed by unaided visual examination (UVE)	Under illumination in the dental unit, a UVE of the proximal surfaces of the patient's entire dentition was conducted by senior orthodontists 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. Owing to the challenges in applying ICDAS scoring for proximal caries detected using UVE, the classification was either positive (presence of discoloration, surface alterations, or cavitation) or negative.	Immediately following clinical oral examination.

Collaborators and Investigators

• Sponsor: West China College of Stomatology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: WCHSIRB-D-2022-430

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No