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

NCT06276959 | Recruiting

• 1 other identifier: WCHSIRB-D-2022-430
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Proximal caries positive site diagnosed by CBCT

  Immediately following CBCT image interpretation.

• Proximal caries positive site diagnosed by near-infrared imaging (NIRI)

  Immediately following NIRI image interpretation.

• Proximal caries positive site diagnosed by unaided visual examination (UVE)

  Immediately following clinical oral examination.

Study Arms (1)

The population with a potential risk of proximal caries.

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

Interventions

intraoral scanning DIAGNOSTIC_TEST

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

The population with a potential risk of proximal caries.

clinical oral examination DIAGNOSTIC_TEST

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.

The population with a potential risk of proximal caries.

cone-beam computed tomography DIAGNOSTIC_TEST

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.

The population with a potential risk of proximal caries.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China College of Stomatology: lead

Study Sites (1)

West China Hospital of Stomatology, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Tomography, X-Ray; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 26, 2024
• Study Start: January 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CN (1)