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.

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

Study Overview

• Status: Recruiting
• Conditions: Dental Caries; Patient Compliance
• Intervention / Treatment: Device: Near infra red imaging

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

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moti Moskovitz, Prof.; Phone Number: +972-2-6778496; Email: motim@ekmd.huji.ac.il
• Study Contact Backup: Name: Diana Ram, Prof.; Phone Number: +972 544747580; Email: dianar@ekmd.huji.ac.il

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Organization
    • Principal Investigator: Moti Moskovitz, DMD, PhD.
    • Contact: Hadas Lemberg, PhD; Phone Number: 00 972 2 6777572; Email: lhadas@hadassah.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare users' experience using a qualitative questionnaire	Qualitative users' feedback will be collected through questionnaire relating to: chair time, the ability to capture tooth surfaces (reachability), patient's experience (gag reflex, discomfort),what Frankl rating would reflect the patient's behavior during the procedure,what is the patient legal guardian's compliance to approve the procedure, if and how the 3D model of the scan assists as a patient communication tool	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare carious lesions depth as appears in NIRI and BWR images to clinical depth observed during caries excavation	Lesion depth will be documented in cases where caries debridement was conducted. NIRI and BWR images will be compared to the clinical findings	During the study period and up to 6 months from last subject visit

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Moti Moskovitz, Prof., Hadassah Medical Center, Faculty of Dental Medicine, Hebrew University of Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Estimated): December 8, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: March 19, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 0351-22-HMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: After publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No