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 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT07167394
Eligibility Criteria:
Inclusion Criteria:
* Children aged 6 to 10 years
* No previous dental treatment history
* No systemic or chronic medical conditions
* No mental retardation
* No psychiatric pathology based on CBCL, K-SADS-PL-T, and SCARED (SCARED score \<25)
* Presence of dentin caries on mandibular molars (mesio-occlusal or disto-occlusal)
* Signed informed consent by parent/Guardian
Exclusion Criteria:
* Prior dental treatment experience
* SCARED score ≥25
* Diagnosed psychological or developmental disorders
* Acute dental pain or irreversible pulp involvement
* Decline to sign informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
10 Years
Study:
NCT07167394
Study Brief:
Protocol Section:
NCT07167394