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

NCT ID: NCT05792631

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2024-06-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients scheduled for radiographic dental caries assessment

BWR-The most common type of dental x-ray taken during a routine dental checkup is called a "bitewing radiograph." This type of X-ray shows the upper and lower back teeth in a single view and is taken to see how the upper and lower teeth line up, to check for decay, and discover bone loss due to infection and serious gum disease.

Group Type: OTHER

Near infra red imaging

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ages 4-9 years
• Subjects scheduled for bilateral BWR as part of their standard of care
• Subjects with a recent bilateral BWR which were obtained up to 14 days prior to study visit

Exclusion Criteria

• Subjects who have been diagnosed with epilepsy
• Subjects with a known allergy to latex or plastic
• Subjects with allergies to any dental or oral health products
• Subjects who have undergone a dental treatment since the acquisition of the recent bilateral BWR

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Moti Moskovitz

Prof. Moti Moskovitz DMD, PhD. Director of Postgraduate Program-Dept. of Pediatric Dentistry, Hadassah Medical Center, Faculty of Dental Medicine, Hebrew University of Jerusalem, Israel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moti Moskovitz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Center, Faculty of Dental Medicine, Hebrew University of Jerusalem, Israel

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Moti Moskovitz, Prof.

Role: CONTACT

motim@ekmd.huji.ac.il

+972-2-6778496

Diana Ram, Prof.

Role: CONTACT

dianar@ekmd.huji.ac.il

+972 544747580

Facility Contacts

Hadas Lemberg, PhD

Role: primary

lhadas@hadassah.org.il

00 972 2 6777572

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

0351-22-HMO

Identifier Type: -

Identifier Source: org_study_id