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 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT03889535
Eligibility Criteria:
Inclusion Criteria:
1. Incisors with large carious lesions not restorable with intra-coronal restorations
2. Incisors that have received pulp therapy
3. Incisors that have been fractured and have lost an appreciable amount of tooth structure
4. Incisors with multiple hypoplastic defects or developmental disturbances
5. Incisors with small interproximal lesions with large areas of cervical decalcification
Exclusion Criteria:
1. Patient is classified as American Society of Anesthesiologists (ASA) III or higher
2. Caries associated with signs and symptoms of irreversible pulpitis and/or clinical evidence of an odontogenic infection
3. There is radiographic evidence of pathological root resorption, root fracture secondary to trauma or periapical radiolucency, iv) lacking adequate dental coronal structure to allow restoration with full coverage restoration
4. Patient has non-English speaking parents.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
48 Months
Study:
NCT03889535
Study Brief:
Protocol Section:
NCT03889535