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

NCT05792631 | Unknown

• 1 other identifier: 0351-22-HMO
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Caries; Patient Compliance

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of the iTero 5D compared to BWR in dental caries detection

  For each subject, the Investigator will grade carious lesions in the BWR and Element intra-oral scan (NIRI) according to ADA staging guidelines. The results will be documented using Caries Evaluation Forms for BWR and for Element intra-oral scan . The Investigator will assess and document the findings of each diagnostic test separately before reviewing the next test. The iTero 5D performance will be non-inferior to BWR performance in detecting the existence of primary interproximal caries lesions above the gingiva in pediatric population. The study will include an interim analysis to assess the iTero Element 5D system usability among the first 20 pediatric subjects.

  Grading the carious lesions for the first 20 subjects will be conducted up to 2 month from completion the first 20 subjects visits. The rest 50 subjects will be evaluated up to 1 month from completion the last subject visit.

Secondary Outcomes (1)

• To compare users' experience using a qualitative questionnaire

  The questionnaire will be filled immediately after the intra-oral scan for each subject. Final report of the comparison will be generated up to 15 weeks from last subject visit.

Other Outcomes (1)

• To compare carious lesions depth as appears in NIRI and BWR images to clinical depth observed during caries excavation

  During the study period and up to 6 months from last subject visit

Study Arms (1)

Patients scheduled for radiographic dental caries assessment

OTHER

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.

Device: Near infra red imaging

Interventions

Near infra red imaging 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.

Patients scheduled for radiographic dental caries assessment

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Dental Caries; Patient Compliance

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Moti Moskovitz, Prof.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moti Moskovitz, Prof.

CONTACT

+972-2-6778496; motim@ekmd.huji.ac.il

Diana Ram, Prof.

CONTACT

+972 544747580; dianar@ekmd.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: March 31, 2023
• Study Start: December 8, 2022
• Primary Completion: December 8, 2023
• Study Completion: June 1, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication

Locations

IL (1)