The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth
NCT ID: NCT06276959
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2023-01-01
2025-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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The population with a potential risk of proximal caries.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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West China College of Stomatology
OTHER
Responsible Party
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Xia Kai
Attending physician
Locations
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West China Hospital of Stomatology, Sichuan University
Chengdu, Sichuan, China
Countries
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Facility Contacts
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Other Identifiers
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WCHSIRB-D-2022-430
Identifier Type: -
Identifier Source: org_study_id
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