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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276959
• Other study ID #: WCHSIRB-D-2022-430
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: West China College of Stomatology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
China	West China Hospital of Stomatology, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China College of Stomatology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.