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 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT04274569
Eligibility Criteria:
Inclusion Criteria:
* Generally healthy children age between 3-4 of age with unremarkable medical history and at high caries risk with at least one carious lesion (precavitated or cavitated) (Agouropoulos et al 2014). The high caries risk children are chosen because it is anticipated that they will benefit more from the topical fluoride varnish application than the low caries risk children.
Exclusion Criteria:
* Patients who had received professional fluoride application in the past 6 months
* Patients with underlying medical history or special health care needs
* Patient who are uncooperative or refuse the treatment
* Patient who are allergic to milk protein (as MI VarnishTM contains "casein, a milk protein)
* Patient with contraindication for fluoride varnish e.g. hypersensitivity to colophony and/or any other constituents
* Patient who have primary teeth with enamel hypoplasia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
4 Years
Study:
NCT04274569
Study Brief:
Protocol Section:
NCT04274569