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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT07136051
Eligibility Criteria:
Inclusion Criteria:
* Healthy children aged 8-15 years.
* Fully erupted or completely impacted teeth that are clinically and radiographically confirmed to be caries-free or present with demineralized fissures scored as ICDAS 1-2.
* Children demonstrating cooperative behavior, with a Frankl Behavior Rating Scale score of 3 or 4.
* Oral Hygiene Index (OHI-S) score ≤ 3
* Written informed consent obtained from the parent or legal guardian.
Exclusion Criteria:
* Partially erupted second permanent molars
* Teeth presenting with severe hypoplasia, hypomineralization, extensive restorations, or cavitated carious lesions.
* History of systemic disease or long-term medication use.
* Known allergy to resin-based or glass ionomer materials.
* Presence of parafunctional habits.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
15 Years
Study:
NCT07136051
Study Brief:
Protocol Section:
NCT07136051