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 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT04902495
Eligibility Criteria:
Inclusion Criteria:
* Responsible patients or parents or guardians who demonstrate that they understand the study and are willing to participate, as evidenced by signing the voluntary informed consent and receiving a signed and dated copy of the informed consent form.
* Children under 18 years of age with informed parental consent, correctly understood.
* Patient understands and is willing to comply with all study procedures and restrictions.
* Absence of clinical and radiographic evidence of pulp degeneration such as excessive bleeding, internal and / or external root resorption, destruction of the furcation.
* Asymptomatic and vital primary molars whose pulp exposure occurred during caries removal.
Exclusion Criteria:
* Patients with systemic pathologies (diabetes, inmunosuppresed or any clinically significant or relevant oral abnormality).
* Previous history of allergic reaction to local anesthesics or to the different constituents of the pulp agents to be studied.
* Pulp diagnosis of irreversible pulpits or pulp necrosis, root resorption, root fractures, pathological mobility, spontaneous pain, impossibility of restoration, and if pulpotomy is not the treatment of choice.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
9 Years
Study:
NCT04902495
Study Brief:
Protocol Section:
NCT04902495