Clinical trial NCT05792631: A Study to Compare Caries Detection in the Pediatric Population Between the iTero Element 5D System and Bitewing Radiographs
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries
Patient Compliance
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Non-inferiority of the iTero 5D compared to BWR in dental caries detection
timeFrame: 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:
measure: To compare users' experience using a qualitative questionnaire
timeFrame: 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:
measure: To compare carious lesions depth as appears in NIRI and BWR images to clinical depth observed during caries excavation
timeFrame: During the study period and up to 6 months from last subject visit
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Center, Faculty of Dental Medicine, Hebrew University of Jerusalem, Israel
name: Moti Moskovitz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: