Status:
NOT_YET_RECRUITING
Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars
Lead Sponsor:
Riyadh Elm University
Conditions:
Clincal Evaluation of BioFlx Vs. Zirconia Crowns
Eligibility:
All Genders
5-9 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to clinically evaluate the performance of BioFlx in comparison to preformed zirconia crowns in the restoration of primary second molars in pediatric patients. The m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06895707
Start Date
May 1 2025
End Date
November 1 2027
Last Update
March 30 2025
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