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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT05733468
Eligibility Criteria:
Inclusion Criteria:
1. Patient should be between 9-14 years of age
2. Intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain
3. Permanent molar tooth with deep caries and subsequent pulp bleeding evident upon excavation of caries.
4. Rapid exposure to dramatic temperature changes elicited heightened and prolonged episodes of pain even after the thermal stimulus has been removed
5. Vital bleeding pulp tissue should be present in all canals after complete pulpotomy
6. Diagnosis should be irreversible pulpitis.
7. The tooth is restorable and free from advanced periodontal disease
8. Soft tissues around the tooth are normal with no swelling or sinus tract
9. Haemostasis should be achieved after complete pulpotomy
10. The patient has non-contributory medical history
Exclusion Criteria:
1. Teeth with immature roots
2. Non-restorable
3. Pathological mobility
4. Pus discharge through an associated sinus tract
5. Swelling of associated tissues
6. Radiographic internal or external resorption or with any periapical rarefaction
7. Necrotic pulp upon exposure.
8. Bleeding beyond 25 minutes
9. Children with severe systemic illness (mental retardation/ severe psychotic disorders), prior history of allergy and any medical condition not permitting the intervention.
10. Parents and patients unwilling for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
14 Years
Study:
NCT05733468
Study Brief:
Protocol Section:
NCT05733468