Oral colonization by KABPTM-052 and KABPTM-051: A Randomized, Double-Blinded, Placebo-Controlled Trial (Pilot Study).

BACKGROUND

To determine the oral colonization capacity of the strains KABPTM-052 (CECT 7480) and KABPTM-051 (CECT 7481) in healthy subjects.

MATERIAL AND METHODS

This randomized, double-blinded, placebo-controlled study included 40 volunteers (22 females, 18 males; age range 18-55 years) with healthy gingiva or mild gingivitis, allocated to receiving probiotic chewing gum (n=20) or placebo (n=20) b.i.d for 6 weeks. At baseline and after 6 weeks of treatment, a periodontics specialist collected saliva samples to assess probiotic colonization by qPCR, and analysed dental plaque, gingival index and dental probing pocket depth in Community Periodontal Index (CPI) teeth subset. Protocol was registered as NCT03540498.

RESULTS

Treatment compliance was high (99%). Both and were detected in the oral microbiota at baseline. After 6 weeks, volunteers receiving probiotic showed a significant increase of both ( = 0.017) and ( = 0.004) versus placebo. This effect remained significant after adjusting for gender and gingival index at baseline. In the probiotic group, reduction in plaque index significantly correlated to higher levels of (rho = 0.57, = 0.022) but not of at study endpoint, and the number of subjects with dental plaque was reduced during intervention (7 of 17, = 0.016). No such effects were observed in the placebo group. No adverse drug reactions were reported.

CONCLUSIONS

KABPTM-052 and KABPTM-051 colonize the buccal microbiota of healthy volunteers, and higher colonization by positively correlated to reduction in dental plaque.  Probiotic, Levilactobacillus brevis, Lactiplantibacillus plantarum, oral colonization, oral microbiota, dental plaque.