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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT07239050
Eligibility Criteria:
Inclusion Criteria:
* Healthy children, American Society of Anesthesiologists class I, II
* Cooperative children during preoperative assessments according to the Frankl'
* Behavioral Rating Scale (scores 3 or 4)
* Patient presenting with at least one hypersensitive SCASS 2,3 \[22\] (Appendix III) deeply carious, MIH-affected FPM, with caries extending to the inner third of the dentin and close to the pulp, as shown in the periapical radiograph, consistent with TNI 4c classification for MIH
* Written consent of the legal guardian.
Exclusion Criteria:
* Any physical or mental disability or psychological problems.
* Immunocompromised patients.
* Hypersensitivity to local anesthetic drugs used.
* Taking analgesics or other medications that alter the child's behavior or awareness of pain 12- hours pre-operatively
* Patients requiring emergency treatment.
* FPM with preoperative signs and symptoms of clinical failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
9 Years
Study:
NCT07239050
Study Brief:
Protocol Section:
NCT07239050