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:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT06897020
Eligibility Criteria:
Inclusion Criteria:
* The Inclusion criteria:
1. Children aged four to eight years old who are appearing healthy and free of any systemic disease according to parental history.
2. Frankl's positive and definitely positive children.
3. Children whose parent or guardian are willing to sign an informed consent.
4. Children whose parent or guardian are willing to comply with follow-up visits.
5. Primary molars indicated for crowns. • Exclusion criteria:
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1. Children with
Exclusion Criteria:
* The Exclusion criteria:
1. Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.
2. Children with history of allergies; Known allergies to dental local anesthesia or to the materials used in Bioflx crowns.
3. Child with parafunctional habits.
4. Molars with severe structural loss that may compromise crown retention.
5. Presence of malocclusion such as crossbite or scissor bite.
6. Primary molar with root caries.
7. Primary molar with root resorption or furcation involvement.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
8 Years
Study:
NCT06897020
Study Brief:
Protocol Section:
NCT06897020