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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07445594
Eligibility Criteria:
Inclusion Criteria:
1. Children aged 6-10 years requiring restorative dental treatment.
2. Indication for dental treatment under local anesthesia.
3. Ability to understand and respond to dental anxiety and pain assessment scales (CFSS-DS and Wong-Baker Faces Scale).
4. Children classified as ASA I or ASA II.
5. No prior exposure to the distraction materials used in the study during dental treatment.
6. Written informed consent obtained from parents or legal guardians.
Exclusion Criteria:
1. Presence of systemic diseases or medical conditions affecting stress response or contraindicating routine dental treatment
2. History of psychiatric, neurological, or developmental disorders that may impair cooperation or communication
3. Use of medications influencing anxiety, pain perception, heart rate, or cortisol levels
4. Requirement for sedation or general anesthesia for dental treatment
5. Acute dental infection or emergency treatment requiring immediate intervention
6. Refusal of participation by the child or parent/legal guardian
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
10 Years
Study:
NCT07445594
Study Brief:
Protocol Section:
NCT07445594