To evaluate the adjunctive use of the probiotic Bifidobacterium animalis subsp. lactis HN019 (B. lactis HN019) to conventional therapy on clinical and microbiological parameters in patients with generalized gingivitis. Sixty systemically healthy individuals with untreated generalized gingivitis were submitted to periodontal therapy and allocated to receive Placebo (n = 30) or Probiotic (n = 30) lozenges, twice a day for 8 weeks. Bleeding on Marginal Probing (BOMP) was evaluated at baseline, after 2 and 8 weeks. Supra and subgingival biofilm were obtained at baseline and 8 weeks post-therapy for analyses by 16S rRNA gene sequencing. Differences between therapeutic groups were analyzed by non-parametric tests (p<0.05). The Placebo and Probiotic groups showed a significant reduction in BOMP at 8 weeks compared to baseline (p<0.05). The Probiotic group had a lower percentage of BOMP when compared with the Placebo group at 8 weeks (p<0.0001). Alpha and beta-diversity showed no statistical significance between groups and time points. At phylum level, no significant differences were observed between groups and time points. At genus level, an increase in the relative abundances of Bergeyella and Corynebacterium were significantly associated with a greater reduction in bleeding in the Placebo group and with less reduction in bleeding in the Probiotic group, respectively. At species level, Schaalia spp., Streptococcus gordonii, and Leptotrichia wadei increased in Placebo and decreased in the Probiotic group after treatment. Granulicatella adiacens decreased significantly after the probiotic therapy, while Saccharibacteria (TM7) spp., Solobacterium moorei, and Catonella morbi increased significantly. In the Placebo group, Bergeyella sp. HMT-322 was associated with a greater percentage of reduction in bleeding. In both groups, Actinomyces species were related to less reduction in bleeding. The adjuvant use of B. lactis HN019 alongside conventional therapy enhanced the reduction in BOMP and promoted greater changes in the microbiological profile of patients with generalized gingivitis. The study was registered at Brazilian Clinical Trials Registry (ReBEC; protocol number: RBR-59v2yb).
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