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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT06999005
Eligibility Criteria:
Inclusion Criteria:
* Children aged between 6 and 12 years at the time of enrollment
* Presence of at least one erupted permanent first molar
* Diagnosis of active caries lesions classified according to ICDAS (scores 1 to 6)
* Written informed consent signed by a legal guardian and assent signed by the child
* Ability to attend quarterly follow-up visits over a 24-month period
Exclusion Criteria:
* Children requiring endodontic treatment or presenting extensive pulpal involvement
* Presence of systemic diseases or medical conditions that contraindicate dental care
* Known allergy to any material used in the study (fluoride varnish, high-viscosity glass ionomer cement)
* Participation in other clinical dental studies that could interfere with the outcomes
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT06999005
Study Brief:
Protocol Section:
NCT06999005