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Cheng Crowns
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Restorative

90 - A 36-Month Randomized Controlled Trial Comparing SSCs vs. BioFlx Crowns

Friday, May 23, 2025
12:40 PM - 1:00 PM MDT
Has Audio

    Presenting Author(s)

  • James H. Chao, DDS

    Pediatric Dentistry Resident
    Cincinnati Children’s Medical Center Hospital, Cincinnati, OH
    Cincinnati, Ohio, United States

    • Research Mentor(s)

  • Patrick T. Ruck, DDS (he/him/his)

    Assitant Professor
    Cincinnati Children’s Medical Center Hospital, Cincinnati, OH
    Cincinnati, Ohio, United States

    • Program Director(s)

  • Scott Schwartz, DDS, MPH

    Associate Professor
    Cincinnati Children's Hospital Medical Center
    Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio, United States

Abstract: Background

Preformed stainless-steel crowns (SSC) are the gold standard for full coverage pediatric dental restorations. The clinical drawbacks of SSC include their esthetic appearance with parental acceptance. In 2023 a new commercial preformed resin-crown product BioFlx by NuSmile became available. The material is based on an existing biocompatible hybrid resin polymer. However, due to its novelty, there is no empirical data to support successful long-term clinical outcomes.  
Methods 

This will be a 36-month prospective, randomized controlled, split-mouth pilot study. Patients presenting to the CCHMC outpatient dental clinics will be recruited, consented, and enrolled. Potential participants will be planned to have full-mouth dental rehabilitation under general anesthesia. Enrolled patients will require at least one pair of contralateral primary molars with the need for a full coverage restoration in the same arch. Arch side will be randomized to either receive SSCs or BioFlx crowns. Enrolled subjects will be followed-up at 6 month hygiene recall visits postoperatively for 36 months to check for the performance of restorative materials using the modified United States Public Health Service (USPHS) criteria. 
Results

Data collection is ongoing until participants N=50 is reached, factoring in the potential for loss in follow up and ensuring an adequate sample size for statistical evaluation. First study participant scheduled for 6-month follow-up is in January 2025.
Conclusion 

The results of this pilot study will reveal the long-term clinical outcomes of the novel BioFlx crowns in restoring carious primary molars and test this new material as an acceptable esthetic alternative to SSCs.

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