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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT03521492
Eligibility Criteria:
Inclusion Criteria:
* Cases: Patients diagnosed with ECC who are treatment planned to receive full mouth dental rehabilitation under General Anesthesia (GA).
* Age 71 months or younger.
* Patients with an American Society of Anesthesiologists (ASA) Classification of 1 (Healthy person).
* Controls: patients who present with no frank cavitated lesions upon visual and radiographic examination who are:
* Patients of record at SFH for an annual exam with blood work patients will schedule to undergo an otolaryngology procedure under GA.
Exclusion Criteria:
Exclusion Criteria:
* Patients with significant metabolic disorders and/or complex medical issues.
* Patients with an ASA Classification of 2 or greater.
* Patients received vitamin D supply
* Controls: patients who present with frank cavitated lesions upon visual and radiographic examination.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
6 Years
Study:
NCT03521492
Study Brief:
Protocol Section:
NCT03521492