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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT05149651
Eligibility Criteria:
Inclusion Criteria:
1. Patient inclusion criteria
* ASA 1 patient, Patient is a completely healthy \& fit. No allergy or medical conditions.
* Patient is indicated for treatment under General Anesthesia: young age, uncooperative and extensive treatment plan.
* Parent agreed to participate in the study, and signed the written consent.
* Patient attended the out-patients pediatric dental clinic in UZ Gent.
2. Tooth inclusion criteria 2.1. Clinical inclusion criteria:
* Vital primary molars (first or second) with deep caries cavity with pulpal exposure.
* Only mandibular primary molar were included
* No spontaneous pain
* No history of swelling
* No sinus tract/ fistula
* Absent of tenderness in percussion
* No pathological mobility
* Restorable tooth (stainless steel crown can be placed)
* Hemostasis can be achieved with a dry cotton pellet after removal of Coronal pulp.
2.2. Radiographical inclusion criteria:
* At least 2/3rd of root is present
* Absence of internal or external root resorption
* Absence of pathologic root resorption
* Absence of periapical or furcation radiolucency
Exclusion Criteria:
If one or more of the criteria mentioned above is not fulfilled, the teeth were excluded from the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
9 Years
Study:
NCT05149651
Study Brief:
Protocol Section:
NCT05149651