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 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT02601833
Eligibility Criteria:
Inclusion Criteria:
* Presence of at least one active (soft) cavitated carious lesions in the primary dentition, extending into dentin (ICDAS 5 or 6)
* The selected tooth must have a one or two surface lesion (more than 1/3 of the crown of the tooth must be remaining) and must allow for direct application of SDF
* Study teeth will not have any spontaneous or elicited pain due to caries, tooth mobility, or signs of pulpal infection
* Selected primary teeth must have an anticipated exfoliation date greater than 12 months away
Exclusion Criteria:
* Hereditary developmental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
* Severe medical conditions that do not allow the child to be managed in the clinic
* Known allergy /sensitivity to dental materials being used, including SDF
* Inability of the child to cooperate for treatment, recall examinations, or periapical radiographs
* Wards of the State, for consenting reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
10 Years
Study:
NCT02601833
Study Brief:
Protocol Section:
NCT02601833