Comparative evaluation of clinical success of Stainless Steel and Bioflx crowns in primary molar – A 12 month split mouth prospective randomized clinical trial

Abstract

Purpose: The purpose of this clinical trial was to assess and compare the clinical outcomes of Bioflx crowns (BFCs) with stainless steel crowns (SSCs) in primary molars (PMs). Materials and Methods: This prospective split-mouth randomized controlled clinical trial was conducted between March 2022 and June 2023. Thirty-eight patients (17 females and 21 males) with a mean age of 5.21 years participated in this study. Each child (n = 38) received both SSC and BFC. Clinical and radiographic follow-up was performed at baseline, 3, 6, and 12 months using the modified United States Public Health System scoring criteria to evaluate various parameters. Results: At the 3 and 6 months’ follow-up, no significant difference was observed between the two groups. However, at 1-year follow-up, a statistically significant difference (P < 0.05) was evident in the frequency between the two groups for the criteria of crown retention after cementation and anatomic form of the crown, indicating a preference for SSC over prototype 1 BFC. Conclusion: The 12-month results indicate that BFC performed similarly to the established SSC for the restoration of PMs providing better esthetics.