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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT07069218
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged between 6 and 18 years
* Ability to understand and follow instructions in Italian or English
* Signed written informed consent provided by the parent/legal guardian and assent from the minor
* Good cooperation and adherence to clinical instructions
* Fully erupted permanent first molars and upper central incisors in good general condition
* DIAGNOdent Pen baseline values in the C1 (0-12) or C2 (13-24) range
Exclusion Criteria:
* DIAGNOdent Pen values greater than 25
* Ongoing systemic antibiotic therapy
* Presence of sealants or composite restorations on first permanent molars or upper central incisors
* Severe enamel alterations such as molar-incisor hypomineralization (MIH), fluorosis, or extensive white/brown spot lesions
* Poor motivation or limited compliance with study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT07069218
Study Brief:
Protocol Section:
NCT07069218