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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT07289932
Eligibility Criteria:
Inclusion Criteria:
\- A minimum of one tooth affected by early carious lesions (ICDAS-II codes 1 or 2) in both sides of the mouth that do not require invasive treatment.
* Age 15 years and ≤ 25 years
* Size and form of the carious lesions must both be fully visible, and accessible
* Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
* Provide written informed consent before participation in the study as subjects were minors, informed consent will provided by the parent and/or legal guardian.
* patients not on medication affecting their salivary flow and medically free (ASA class I).
Exclusion Criteria:
* Evidence of tooth erosion.
* any form of fluoride application before the study treatment.
* patients with hypoplastic enamel defects, multiple restorations on the facial surfaces.
* High caries risk patients
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
25 Years
Study:
NCT07289932
Study Brief:
Protocol Section:
NCT07289932