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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT06583759
Eligibility Criteria:
Inclusion Criteria:
1. Participant Inclusion Criteria
* Age ranges from 5 - 7 years.
* Children free of any systemic disease or special health care need (ASA I).(30)
* Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4) (Appendix I).(31)
* Patients whose parents will give their consent to participate.
2. Tooth Inclusion Criteria
* Mandibular second primary molars that are indicated for full coverage:(7)
* Present opposing tooth.
Tooth Exclusion Criteria:
* Root resorption affecting more than one third of the root length.
* Clinical signs and symptoms of irreversible pulpitis or non-vitality. (Appendix II) (32)
* Fistula or abscess related to the selected tooth clinically and radiographically.
* Non restorable crowns.
* Signs of mobility or bone resorption.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
7 Years
Study:
NCT06583759
Study Brief:
Protocol Section:
NCT06583759