Clinical Performance and Immediate Child and Parental Satisfaction with BioFlx Crowns in Primary Molars: A Prospective, Single-Arm, Non-Randomized Interventional Study

Abstract

Background/Objectives: BioFlx crowns have recently been introduced as an aesthetic full-coverage option for restoring primary molars; however, clinical evidence remains limited. This prospective, single-arm, non-randomized interventional study evaluated the short-term clinical performance of BioFlx crowns in primary molars over six months and assessed immediate satisfaction of children and their parents after crown placement. Methods: Healthy children aged 6–9 years or children with mild, stable systemic medical conditions who were cooperative and required at least one full-coverage restoration in a primary molar were recruited from the pediatric dentistry clinics at King Abdulaziz University Faculty of Dentistry. BioFlx crowns were placed by trained pediatric dentistry residents under a consultant’s supervision. Immediately after crown cementation, proximal contact and occlusion were recorded. At three- and six-month follow-up visits, clinical outcomes evaluated were the proximal contacts, occlusion, crown retention, staining, wear of the opposing tooth, marginal integrity, and any changes in the crown material surface. In addition, plaque accumulation and gingival health around each crowned tooth were assessed at the tooth level. Immediate post-treatment satisfaction of children and their parents was assessed following crown cementation. Results: Twenty-eight children received 71 BioFlx crowns. The gingival health was favorable, with most teeth showing no bleeding throughout the follow-up visits. At six months, all evaluated crowns maintained ideal occlusion and showed no opposing-tooth wear; 98.4% remained retentive, 91.8% showed no staining, 93.4% maintained ideal marginal integrity, and minor surface indentations were common at 59%, while perforations were limited to 4.9% at six-month assessment. Children and parents reported high overall satisfaction with appearance (9.8 ± 0.4 and 9.5 ± 0.8, respectively). Conclusions: Within the selected cohort, BioFlx crowns demonstrated favorable short-term clinical performance over six months and high immediate post-treatment satisfaction among children and parents; however, surface indentations were frequently observed, and occasional clinically unacceptable perforations were noted.

The authors' abstract, as published at the source. Children, 2026 · DOI ↗