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 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT03649659
Eligibility Criteria:
Inclusion Criteria:
* Child:
* Male or female, between 12-71 months of age at baseline, up to the day the child turns 6 years old.
* Must allow examination of the oral cavity and application of treatment by the examiners at baseline.
* Must have S-ECC \[defined as: In children younger than age 3, any sign (non-cavitated or cavitated lesion) of caries in any tooth surface (i.e., most common for this age group will be on erupted smooth surfaces). From ages 3 through 5, ≥1 dmfs in maxillary anterior teeth; or a dmfs score of ≥4 (age 3), ≥5 (age 4), or ≥6 (age 5) constitutes S-ECC. Note: The "d" component of the dmfs index is defined as including cavitated and non-cavitated lesions, thus ICDAS\>1\].
* Have at least one SDF-target tooth with
* Soft cavitated caries lesions extending into dentin \[ICDAS 5 or 6\];
* Cavitated lesion(s) that allow for direct hardness assessment and application of SDF (microbrush applicator must fit the cavity and be able to access all exposed dentin).
* Parent/Legal Guardian:
* Provide written informed consent for the child and her/himself prior to participation.
* Must be at least 18 years old, or an emancipated minor who provides documentation of emancipation.
* Must be willing and able to participate in trial activities.
Exclusion Criteria:
* Child:
* Hereditary generalized developmental dental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta.
* Known allergy/sensitivity to silver or other heavy metal ions.
* Presence of any gingival or peri-oral ulceration, abscess or stomatitis.
* Participating in the foster care system at trial initiation.
* Toothache pain at baseline (based on Dental Discomfort Questionnaire score of 1 or higher).
* Note: If toothache pain occurs after baseline, the child remains eligible to continue in the trial as long as he/she has at least one trial tooth that meets tooth inclusion/exclusion criteria.
* Demonstrated inability to comply with trial protocol requirements (determination is at the Clinical Site Investigator's discretion).
* Rickets.
* Osteopenia or osteoporosis (e.g., Osteogenesis Imperfecta, Ehlers-Danlos Syndrome, Marfan Syndrome, etc.).
* Chronic diseases such as chronic kidney disease, leukemia, lymphoma, rheumatic disorders, etc.
* Metabolic bone disease (e.g., Galactosemia, Glycogen Storage Disease Type 1, etc.).
* Chronic glucocorticoid, anticonvulsants, chemotherapy, bisphosphonate administration.
* Hypothyroidism, hyperparathyroidism, impaired glucose tolerance, hypocalcemia or hypophosphatemia.
* Tooth:
* Pain due to caries (based on DDQ score of 1 or higher).
* Note: If toothache pain occurs after baseline, the tooth is removed from the study.
* Pulpal exposure, or signs of pulpal infection (abscess, fistula, swelling).
* Mobility not associated with expected exfoliation patterns.
* Parent/Legal Guardian:
* Demonstrated inability to comply with trial protocol requirements (determination is at the Clinical Site Investigator's discretion).
* Inability to read and comprehend the consent document or trial questionnaires in the translated languages available.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
71 Months
Study:
NCT03649659
Study Brief:
Protocol Section:
NCT03649659