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

Hadassah Medical Center

Status: Enrolling

Conditions: Dental Caries; Patient Compliance

Treatments: Device: Near infra red imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT05792631

0351-22-HMO

Details and patient eligibility

About

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

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 4 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Patients scheduled for radiographic dental caries assessment

Other group

Description:

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.

Treatment:

Device: Near infra red imaging