Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT02395120
Eligibility Criteria:
Inclusion Criteria: (parents/caregivers and their children)
* Provide signed and dated consent form (also assent form for children 7 and older)
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female child, grades K-4
* Child in good general health as evidenced by parent report (including children with special health care needs)
* Based on the beginning of the school year dental screening, caregivers will be randomized if their child has tooth with an International Caries Detection and Assessment System (ICDAS) active lesion score of ≥ 2
Exclusion Criteria: (parents/caregivers)
* Illiterate
* Non-English speaking (in East Cleveland Public Schools)
* Under 18 years of age
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
10 Years
Study:
NCT02395120
Study Brief:
Protocol Section:
NCT02395120