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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT06968767
Eligibility Criteria:
Inclusion Criteria:
* Children aged between 4 and 8 years with a primary molar that needs to be covered by a crown.
Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification).
Children whose parent or guardian is willing to sign an informed consent.
Children whose parent or guardian are willing to comply with follow-up visits.
Frankl's positive and definitely positive patient.
Exclusion Criteria:
* Molars with severe structural loss that may compromise crown retention.
Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.
Children with a history of allergies; known allergies to dental local anesthesia or to the materials used in Biofix crowns.
Children with any systemic conditions or disabilities that may affect their ability to participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
8 Years
Study:
NCT06968767
Study Brief:
Protocol Section:
NCT06968767