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:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT04054635
Eligibility Criteria:
Inclusion Criteria:
1. Child is \< 72 months of age with early childhood caries (ECC) with active lesions (International Caries Detection and Assessment System codes 5 or 6).
2. Child has ≥ 1 primary tooth with caries that is eligible to receive SDF. Eligible primary teeth must: a) have soft cavitated caries lesions extending into dentin; b) the cavitated lesions must allow for direct application of silver diamine fluoride (SDF). Teeth that meet any of the PUFA (pulpal involvement, ulceration, fistula, and abscess) index criteria (i.e. spontaneous pain due to caries, pulp exposure, mobility, signs of pulpal infection such as abscess, fistula, or swelling) will be excluded. However, a child would still be eligible even if they have at least one tooth that meets PUFA criteria, but other eligible teeth with caries do not.
Exclusion Criteria:
1. Child is allergic or has a sensitivity to silver or other heavy metal ions.
2. Child has hereditary generalized developmental defects of enamel (e.g. Amelogenesis Imperfecta, Dentinogenesis Imperfecta)
3. Child has severe medical problems that limit participation.
4. Child requires immediate rehabilitation under general anesthesia (GA) because of severe infection or pain.
5. Antibiotic use within the last 2 weeks.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
72 Months
Study:
NCT04054635
Study Brief:
Protocol Section:
NCT04054635