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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT06841120
Eligibility Criteria:
Inclusion Criteria:
* \- Children whose parents signed the written informed consent form and who themselves gave assent,
* Children with a Frankl behaviour rating scale score of 3 or 4,
* Children aged between 4 and 9 years old who can understand soft tissue sensation and respond to it,
* Children requiring treatment with local infiltration anaesthesia for multiple teeth in both the mandible and maxilla,
* Children with no history of allergy to materials used for anaesthesia or sulphite,
* Children who have not taken any analgesic medication at least 24 hours before treatment,
* Children without any systemic conditions that would interfere with dental treatment under local anaesthesia.
Exclusion Criteria:
* Occurrence of an error during anaesthesia injection resulting in insufficient anaesthesia for treatment,
* Inability of the patient to provide clear assessments of response to soft tissue anaesthesia,
* Presence of systemic conditions that would prevent anaesthesia administration or dental treatment,
* Children requiring urgent dental treatment priority such as acute painful teeth.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
9 Years
Study:
NCT06841120
Study Brief:
Protocol Section:
NCT06841120