One-year clinical and radiographic evaluation of young permanent molars treated with brix 3000 vs. papacárie duo: a randomized controlled clinical trial.

Abstract

Managing deep carious lesions in immature permanent molars presents a clinical challenge. Minimally invasive caries removal helps preserve apexogenesis by minimizing tissue loss. This study evaluated the effectiveness of two chemo-mechanical caries removal (CMCR) agents compared to hand excavation alone in young permanent molars. A three-arm randomized clinical trial included 108 children (8-10 years) with carious first permanent molars. Participants were assigned to: Group I (ART with Brix 3000), Group II (ART with Papacárie Duo), or Group III (ART with hand excavation). Dentin samples were collected before and after caries removal to assess S. mutans and Lactobacilli counts (CFU/ml). Time for caries removal and pain perception were recorded. Clinical and radiographic outcomes were evaluated at 3, 6, and 12 months. OHRQoL was assessed using CPQ8-10 at baseline and during the follow up. The control group showed significantly shorter caries removal time (5.3 min) than Brix 3000 (11.3 min) and Papacárie Duo (12.1 min) (P < 0.01). However, higher pain scores were reported with hand excavation compared to Brix 3000 (P = 0.003) and Papacárie Duo (P < 0.001). Both within- and between-group comparisons showed significant reductions in S. mutans and Lactobacilli, with greater bacterial reduction in CMCR groups than ART alone (P < 0.001). CMCR groups had significantly higher restoration success rates than the control at 6 and 12 months (P = 0.02), and radiographic success was also greater at 12 months (P < 0.05). CPQ8-10 scores improved post-treatment across all groups (P < 0.001), with a notable difference at 6 months (P = 0.008). Brix 3000 and Papacárie Duo were more effective than hand excavation in reducing cariogenic bacteria, minimizing pain, and enhancing restoration longevity in immature permanent molars. Both CMCR methods supported favorable clinical, radiographic, and quality-of-life outcomes over one year. This study was registered in ClinicalTrails.gov (NCT05983900) 09/06/2023, https://clinicaltrials.gov/ct2/show/NCT05983900 .