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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT03384004
Eligibility Criteria:
Inclusion Criteria:
* Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* Aged at least 18 years.
* Understands and is willing, able and likely to comply with all study procedures and restrictions.
* Good general and mental health in the opinion of the investigator or medically qualified designee;
* No clinically significant and relevant abnormalities of medical history or oral examination;
* Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
* Single or multi rooted-canal teeth diagnosed with pulp necrosis and symptomatic/ asymptomatic apical periodontitis as tested with routine diagnostics.
* Radiographic evidence of periapical lesion.
Exclusion Criteria:
* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
* Women who are breast-feeding.
* Pre-existing oral irritations. b) Recent (within 30 days) gingival/oral surgery. c) Any clinically significant or relevant oral abnormality.
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
* Any subject requiring re-treatment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03384004
Study Brief:
Protocol Section:
NCT03384004