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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT04739735
Eligibility Criteria:
Inclusion Criteria:
* Age range from 5 - 7 years.
* Children free of any systemic disease or special health care need (ASA I).
* No previous bad dental experience.
* Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4).
* Patients whom their mandibular primary molars are indicated for extraction:
* Clinical signs and sympmtoms of pulp degeneration, such as swelling or sinus tracts.
* Radiographic evidence of periapical or interradicular radiolucency.
* Non restorable crowns.
* Failed pulpotomies.
* Patients whose parents will give their consent to participate.
Exclusion Criteria:
* Root resorption affecting more than one third of the root length.
* Fractured roots due to trauma.
* Signs of mobility.
* Ankylosed roots.
* Active sites of pathosis in area of injection that could affect anaesthetic assessment.
* History of allergy to local anesthesia.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
7 Years
Study:
NCT04739735
Study Brief:
Protocol Section:
NCT04739735