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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT04394702
Eligibility Criteria:
Inclusion Criteria:
* Children categorized as class I or II according to American Society of Anesthesiologists (ASA).
* Children aged between 4 and 6 years with at least one necrotic primary second mandibular molar.
* History of dull toothache over an extended period of time
* History of spontaneous pain or pain at night
* Swelling adjacent to tooth with or without a sinus tract
* Abnormal tooth mobility
* Presence of necrotic pulp tissue or purulent discharge when the pulp chamber was accessed
* Interruption of lamina dura or thickening of periodontal ligament space
* Furcational radiolucency did not surpass half of the distance between the furcation and permanent successor
* Negative findings of internal root resorption
* External root resorption confined to the apical third and with at least two-thirds of the root length was intact
Exclusion Criteria:
* Uncoperative children or parents/legal guardians
* Sever intellectual, behaviour or emotional problems
* Non-restorable tooth crowns
* Root canal obliteration
* Presence of underlying dentigerous or follicular cysts
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
6 Years
Study:
NCT04394702
Study Brief:
Protocol Section:
NCT04394702