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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT06453005
Eligibility Criteria:
Inclusion Criteria:
1. Children aged 3 to 9 years old.
2. Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars, confirmed through clinical examination and radiographic assessment.
3. Requirement for restorative treatment in the form of either the SMART Hall technique or standard stainless steel crown (SSC) restoration, as determined by clinical assessment.
4. Willingness and ability of the parent/guardian to provide informed consent and ensure the child's attendance at follow-up appointments.
5. Adequate cooperation of the child during dental treatment and evaluation procedures, as determined by the clinician.
Exclusion Criteria:
1. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders) that may compromise treatment outcomes or pose risks during dental procedures.
2. Use of medications known to interfere with dental treatment or healing, such as anticoagulants or immunosuppressants, unless medically managed and deemed safe by the treating healthcare provider.
3. History of adverse reactions to dental materials or procedures that may contraindicate participation in the study.
4. Inability of the child to tolerate local anesthesia or undergo dental treatment due to psychological, behavioral, or developmental factors.
5. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
9 Years
Study:
NCT06453005
Study Brief:
Protocol Section:
NCT06453005