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:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT03388957
Eligibility Criteria:
Inclusion Criteria:
* High to extreme fear of tooth or molar anesthesia and removal (Frankl: Definitely negative).
* Scoring more than 19 points on MCDAS(f).
* Healthy pediatric patients (ASA I) aging 8-10 years.
* Indication for primary tooth or molar extraction.
* Fasting if indicated (severe gag reflex).
* Airway assessment (Mallampati and tonsillar hypertrophy).
Exclusion Criteria:
* Asthma or any other obstructive pulmonary disease.
* Cardiac failure.
* Cardiac arrhythmia.
* Renal failure.
* Diabetes.
* Current use of another ß-adrenoreceptor antagonist.
* Current use of anxiolytic or antidepressant medication.
* Currently in psychotherapy for dental anxiety.
* Systolic blood pressure \<100 mmHg.
* Diastolic blood pressure \<60 mmHg.
* Active Upper respiratory infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
10 Years
Study:
NCT03388957
Study Brief:
Protocol Section:
NCT03388957