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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT06011005
Eligibility Criteria:
Inclusion Criteria:
* Healthy children (ASA I) aged between 7 - 10 years old.
* Needing any maxillary buccal infiltration (anterior, middle, posterior)
* Had no prior history of local anesthesia.
* Frankl behavior III or IV
* Not taking any painkillers, or other drugs that would influence with their pain perception.
Exclusion Criteria:
* History of a medically compromised condition and intellectual disability. § Any allergy to local anesthesia.
* Active pathology at the site of injection.
* Prior history of intra-oral injection.
* Frankl behavior I or II.
* Children/parents not willing to participate in the study. § Needle phobia.
* Patients require treatment under conscious sedation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
10 Years
Study:
NCT06011005
Study Brief:
Protocol Section:
NCT06011005