Short-Term Clinical Evaluation of Bioflx Crowns for Primary Molar Restoration in Children Aged 4-8 Years in Vietnam: A Pilot Observational Study.

Background: Stainless-steel preformed crowns (SSCs) are effective but esthetically unappealing, while zirconia preformed crowns require extensive tooth reduction. Bioflx preformed crowns combine esthetics and minimal preparation.

Aim: To evaluate the clinical effectiveness of Bioflx preformed crowns in restoring primary molars in children aged 4-8 years at Ho Chi Minh City Odonto-Maxillofacial Hospital in Vietnam.

Design: A single-arm pilot observational study (October 2023-June 2024) at Ho Chi Minh City Odonto-Maxillofacial Hospital involved primary molars treated with Bioflx crowns. Variables included clinical features and treatment outcomes, using descriptive statistics and an unpaired t-test.

Results: Forty primary molars from 17 children were treated (mean 2.35 ± 1.62 crowns/child). Most were first molars (55%), lower right quadrant (30%), with caries (65%). At the 3-month follow-up, 90% were rated as "excellent" masticatory ability, with 100% of "excellent" esthetics and restoration integrity, while 95% of crowns had "excellent" marginal adaptation, along with 92.5% healthy surrounding gums.

Conclusion: Short-term evaluation suggests Bioflx preformed crowns may be a promising new, flexible, and durable treatment option for primary molar restoration considering both esthetic and masticatory function. Yet, longer follow-up studies with control groups remain necessary for the long-term clinical evaluation to ensure a comprehensive approach for pediatric patients.

Trial registration: The study received permission for implementation from the Board of Directors of Ho Chi Minh City Odonto-Maxillofacial Hospital and Can Tho University of Medicine and Pharmacy, which has also been confirmed in the document issued by the Ethics Council for Biomedical Research (23.341.HV/PCT-HĐĐĐ) signed on April 12, 2023.