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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT06158451
Eligibility Criteria:
Inclusion Criteria:
* Children:
1. Cooperative children aged 4 -7 years old.
2. Systemically healthy.
* Teeth:
Clinical criteria:
1. Necrotic primary mandibular second molar teeth.
2. Spontaneous pain or tenderness to percussion
3. Deep carious lesion with pulp exposure.
4. Presence of chronic apical abscess or sinus tract Tooth should be restorable. (Thakur et al., 2021)
Radiographic criteria:
1. Coronal-radiographic evidence of a deep carious lesions or lesion approximating pulp
2. Radicular discontinuity of lamina dura, furcation involvement less than or equal to half of shortest root in vertical dimension. (Thakur et al., 2021)
Exclusion Criteria:
* Children:
1. With physical or emotional alteration.
2. Children with systemic disease.
3. Previous history of allergy to antibiotics used in the study.
4. Children that will not attend follow up. • Teeth:
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1. Non restorable carious primary molars.
2. Grade III mobility
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
7 Years
Study:
NCT06158451
Study Brief:
Protocol Section:
NCT06158451