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 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT05441995
Eligibility Criteria:
Inclusion Criteria:
* Healthy children aged 9-17 years who were categorized as class I or II according to the ASA classification.
* Cooperative children (rate 3 or 4 according to Frankl behavior rating scale)
* Presence of a vital mandibular first permanent molar with SIP, the tooth should show deep caries or dental restorations with a history of spontaneous lingered pain precipitated by thermal stimuli. To confirm the diagnosis of irreversible pulpitis, early response to electric pulp and thermal testing was performed.
* No radiographic changes with at least two-thirds of the root must be evident.
Exclusion Criteria:
* Children with severe emotional, intellectual, and behavioral difficulties.
* Necrotic pulp of primary molars.
* Unrestorable crowns
* Positive history of gingival swelling, abnormal mobility, and fistulous tract.
* Presence of radiographic signs of periapical and/or furcation radiolucency, and pathological resorption.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
17 Years
Study:
NCT05441995
Study Brief:
Protocol Section:
NCT05441995