Comparing caries detection methods in children
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.
NA · Hadassah Medical Organization · NCT05792631
This study tests if a new dental imaging system can find cavities in children aged 4-9 better than traditional X-rays.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 4 Years to 9 Years |
| Sex | All |
| Sponsor | Hadassah Medical Organization (other) |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT05792631 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the effectiveness of the iTero Element 5D system in detecting dental caries in children aged 4-9 years compared to traditional bitewing radiographs. Conducted at the Hadassah Medical Center in Israel, the study involves a single visit where participants will undergo both imaging methods. The results will be assessed according to established ADA staging guidelines, allowing for a direct comparison of the two diagnostic approaches. The study is designed to enhance understanding of caries detection in pediatric dentistry.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4-9 years who are scheduled for routine bilateral bitewing radiographs.
Not a fit: Patients with a history of epilepsy or allergies to dental materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of caries detection in children, leading to better dental care outcomes.
How similar studies have performed: While similar studies have explored advanced imaging techniques, this specific comparison of the iTero Element 5D system with traditional methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jerusalem
- Hadassah Medical Organization — Jerusalem, Israel (RECRUITING)
Study contacts
- Principal investigator: Moti Moskovitz, Prof. — Hadassah Medical Center, Faculty of Dental Medicine, Hebrew University of Jerusalem, Israel
- Study coordinator: Moti Moskovitz, Prof.
- Email: motim@ekmd.huji.ac.il
- Phone: +972-2-6778496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Caries, Patient Compliance