NCT05792631

A Study to Compare Caries Detection in the Pediatric Population Between the iTero Element 5D System and Bitewing Radiographs

A Clinical Study to Compare Caries Detection in Children Between the iTero Element 5D System (NIRI=Near Infra Red Imaging) and Bitewing Radiographs (BWR) as a Diagnostic Aid for the Detection of Primary Carious Lesions Above the Gingiva.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Accepted

Summary

This is a non-significant risk, single site, prospective clinical study. The study will be conducted in the department of pediatric dentistry of the faculty of dental medicine of the Hebrew university, Israel

Detailed description

This is a non-significant risk, single site, prospective study to be conducted in the department of pediatric dentistry of the Hadassah Medical Center, Faculty of Dental Medicine, Hebrew University of Jerusalem, Israel. Subject participation will require one visit during which consent, screening, enrollment, and imaging will be performed. Clinical and diagnostic methods to be used during this study are those that are routinely used in the diagnosis of caries in this site, which include bitewing radiographs (BWR). This standard of care is provided for all site's patients, including the patients who don't participate in this clinical study. A standard set of BWR for subjects ages 4-9 years will be taken to include the complete dentition of the subjects. No additional x-ray should be taken for the sole purpose of this trial. In addition to the routine clinical diagnostics, the subjects will be scanned using the 5D system. The investigator will capture a full arch scan of the maxillary arch and mandibular arch of each subject with the iTero Element 5D system. For each subject, the Investigator will grade carious lesions in the BWR and Element intra-oral scan according to ADA staging guidelines. The results will be documented using Caries Evaluation Forms. The Investigator will assess and document the findings of each diagnostic test separately before reviewing the next test. In cases where caries debridement is indicated, carious lesion depth will be documented during and compared to NIRI and BWR images. All treatment decisions will be made according to the standard of care in the clinic and no treatment will be conducted for the sole purpose of the study

Conditions

• Dental Caries
• Patient Compliance

Interventions

Type	Name	Description
DEVICE	Near infra red imaging	The iTero Element 5D is an intra-oral scanner that incorporates near-infrared illumination capabilities used to provide a near-infrared image of the teeth enabling the detection of both occlusal and proximal caries, at the various stages, ranging from initial enamel caries to established caries reaching the DEJ. Near-infrared Imaging (NIRI) is a nonionizing imaging technology that leverages differences in scattering and absorption of near-infrared light depending on the degree of tooth mineralization.

Timeline

• Start date: 2022-12-08
• Primary completion: 2023-12-08
• Completion: 2024-06-01
• First posted: 2023-03-31
• Last updated: 2023-10-26

Locations

1 site across 1 country: Israel