Clinical and Laboratory Performance of ACTIVA BioACTIVE Restorative in Primary Teeth: A Systematic Review of...

Background and Objectives: ACTIVA BioACTIVE Restorative is a resin-ionomer hybrid marketed as a bioactive material for pediatric restorations, yet its specific performance in primary teeth has not been systematically synthesized. The study aim was to evaluate clinical and laboratory outcomes of ACTIVA in primary dentition compared with established restorative materials. Methods: Following a PRISMA-aligned, OSF-registered protocol, PubMed, Scopus, and Web of Science were searched to 18 October 2025 for full-text clinical trials and in vitro studies involving ACTIVA in primary teeth or primary dentin. Eligible designs included randomized or prospective clinical studies and standardized in vitro experiments. Primary outcomes were clinical and radiographic success; secondary outcomes included placement time, shear bond strength, and calcium-ion release. Results: Three randomized clinical trials (86 children, 305 restorations) and one in vitro study met the inclusion criteria. At 12 months, clinical success with ACTIVA ranged from 97.5 to 97.8% versus 95.0-97.8% for bulk-fill and conventional composites. At 24 months, a split-mouth trial reported clinical success of 93.0% for ACTIVA and 95.3% for compomer, with radiographic success of 86.0% and 88.3%, respectively, remaining within the predefined non-inferiority margin. ACTIVA required a mean of 2.4 ± 0.6 min less placement time than compomer. In vitro, shear bond strength to primary dentin was higher for ACTIVA than for an RMGIC (4.29 ± 0.65 vs. 2.47 ± 0.32 MPa), with greater calcium-ion release at 21 days (0.77 ± 0.13 vs. 0.53 ± 0.12 ppm). Conclusions: Within 1-2 years of follow-up, ACTIVA shows clinical performance in primary molars comparable to compomer, bulk-fill, and conventional composites, while offering shorter placement time and favorable bio-interactive behavior.