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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT07292194
Eligibility Criteria:
Inclusion Criteria:
1. Children who were 6-12 years of age, of both sexes.
2. Children who were healthy and medically fit; ASA I .
3. Children who had positive (Class 3) or definitely positive (Class 4) behavior during preoperative behavioral assessments according to the Frankl Scale at the enrollment visit.
4. Children who require bilateral LA infiltration injections for primary teeth, either in the maxilla or mandible, for dental treatment (different types of restoration, stainless steel crowns, pulp therapy, and extractions).
5. Children with positive consent forms approved by their parents/ legal guardians.
Exclusion Criteria:
1. Children who have had a history of unpleasant experiences in medical settings and/or LA injection procedures.
2. Children with any mental, visual, or auditory impairment.
3. Children who have medical or developmentally compromising conditions.
4. Children who had developmental delay problems.
5. Children with a history of chronic disease or use of medication that contraindicate the use of local anesthetics.
6. Children who had active pathosis at the injection site that could affect anesthetic assessment.
7. Patients who have negative (Class 2) or definitely negative (Class 1) behavior during preoperative behavioral assessments according to the Frankl Scale . - -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT07292194
Study Brief:
Protocol Section:
NCT07292194