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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT04636450
Eligibility Criteria:
Inclusion Criteria:
1. Patients between 4 to 8 years old.
2. Both genders.
3. Patients with an indication for pulpectomy for mandibular molars, based on the of Kuo and colleagues criteria (2006).
4. Patients requiring pulpectomy in posterior teeth.
5. Adequate dental structure of the crown.
6. Patients with a remnant structure of at least two-thirds of the root.
7. Patients with a medical file at the Pediatric Dentistry Clinic, Universidad Latinoamericana, Campus Valle.
8. Patients with signed informed consent.
Exclusion Criteria:
1. Patients requiring pulpotomy, extraction, or pulp regeneration therapy.
2. Patients who are older than 9 years.
3. An unrestorable tooth.
4. Internal resorption in the roots visible on radiographs.
5. Teeth with mechanical or carious perforations of the floor of the pulp chamber.
6. Excessive pathologic root resorption involving more than a third of the root.
7. Excessive pathologic loss of bone support, with loss of the normal periodontal attachment.
8. Presence of a dentigerous or follicular cyst.
9. Periapical or interradicular lesion involving the crypt of the developing permanent successor.
10. Patients with the diagnosis of molar incisor hypomineralization (MIH).
11. Patient's whose legal guardian does not provide their informed consent to participate in this study.
12. Uncooperative patients.
Elimination criteria
a. Patients who do not complete the treatment or radiographic follow-up at least at a cut-off point.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
8 Years
Study:
NCT04636450
Study Brief:
Protocol Section:
NCT04636450