Clinical and Biological Evaluation of Chemo-Mechanical Caries Excavation with Brix 3000 in Primary Molars: An 18-Month Prospective Study

Background and Objectives: Caries in primary teeth are characterized by rapid and often asymptomatic progression, with early dentin involvement and potential extension to the pulp. Untreated lesions may lead to complications that affect the development of the permanent dentition. The aim of this prospective study was to evaluate the clinical and biological effectiveness of chemo-mechanical controlled caries excavation using Brix 3000 compared to conventional treatment in primary molars over an 18-month follow-up period. Materials and Methods: A total of 82 children aged 4–7 years were included, each presenting with at least one carious lesion in a primary molar classified as International Caries Detection and Assessment System (ICDAS II) code 05 or 06. The carious lesions were divided into two groups according to the method of excavation: Group 1 (control), which contained 40 lesions treated with conventional bur excavation, and Group 2, which contained 42 lesions treated with chemo-mechanical excavation using Brix 3000. In all cases, excavation was controlled using a fluorescence-based device (ProFace). Clinical performance was evaluated using an assessment protocol adapted from the FDI (Fédération Dentaire Internationale) clinical criteria for the evaluation of direct and indirect restorations, with particular emphasis on biological outcomes. Follow-up examinations were performed after 1 week and 1, 3, 6, 12, and 18 months, and included radiographic evaluations. Results: After 18 months, chemo-mechanical caries excavation with Brix 3000 demonstrated a biological success rate of 100%, with no reported acute symptoms or complications. Esthetic criteria showed a success rate of 65% at 18 months, while anatomical and functional criteria demonstrated success rates of 95% and 98%, respectively. In the conventional bur excavation group, biological success reached 100%, while the esthetic, anatomical, and functional success rates were 61.3%, 93.5%, and 100%, respectively. No significant differences were observed between groups (p > 0.05). Conclusions: Chemo-mechanical controlled caries excavation using Brix 3000 represents a clinically effective and biologically reliable alternative to conventional caries excavation for the treatment of carious lesions in primary molars.