Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars
Launched by RIYADH ELM UNIVERSITY · Mar 19, 2025
Trial Information
Current as of April 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two types of dental crowns—BioFlx crowns and zirconia crowns—to see how well they work for restoring primary lower second molars in children aged 5 to 9 years. The main focus is to find out if there are differences in how well these crowns stay in place and how they affect the health of the gums, tooth wear, and overall appearance over time.
To participate, children should be between 5 and 9 years old and need two primary lower second molars that need full coverage restorations. They will come in for two appointments: one for each type of crown. After getting the crowns, children will return for check-ups at 3, 6, and 12 months to see how they’re doing. It’s important to note that children with certain medical conditions or those who cannot have local anesthesia will not be eligible for the study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Children aged 5-9 years old.
- • American Society of Anesthesiologists Classification I or II status.
- • Cooperative child.
- • Obtained informed consent.
- • Two primary lower second molars requiring full coverage restorations.
- • Primary lower second molars in functional occlusion with the opposing tooth and have at least one contact area with an adjacent tooth.
- • Primary lower second molars that can be adequately isolated.
- • Pulptomized primary lower second molars.
- • Primary lower second molars with multi-surface caries.
- Exclusion Criteria:
- • American Society of Anesthesiologists Classification higher or equal to three statuses.
- • Informed consent is not obtained.
- • Allergy to local anesthesia.
- • Non-restorable primary lower second molars.
About Riyadh Elm University
Riyadh Elm University is a leading educational and research institution in Saudi Arabia, dedicated to advancing healthcare through innovative clinical research and evidence-based practice. Committed to fostering academic excellence and community health, the university collaborates with local and international partners to conduct clinical trials that aim to improve patient outcomes and contribute to the global body of medical knowledge. With a focus on ethical standards and regulatory compliance, Riyadh Elm University seeks to drive advancements in medical science while prioritizing the safety and well-being of participants involved in its research initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported