AIM: This study aimed to evaluate the clinical effectiveness of the probiotic Lactobacillus reuteri as an adjunct to non-surgical periodontal therapy (NSPT). MATERIALS AND METHODS: A double-blind, paralleled-arm, placebo-controlled and randomized clinical trial was conducted. Probiotics L. reuteri or placebo lozenges were randomly prescribed for use twice-daily for 28 days. Primary outcomes were clinical attachment levels (CAL) and probing pocket depths (PPD). All participants underwent NSPT, and follow-up clinical assessments were performed at day 90 and day 180. RESULTS: The trial response rate was 69.5% (41 out of 59). Among the test and control groups, there were significant intra-group differences in primary outcomes: CAL (both, p < .001) and PPD (both, p < .001); and in secondary outcomes: percentage of sites with 'bleeding on probing' (both, p < .001) and visible plaque (both, p < .001). There were no statistically significant inter-group differences in any outcomes at any time points (all, p > .05) nor in the changes in outcomes (∆) with time (all, p > .05). There was a trend of a greater magnitude of statistical change occurring among the test group compared to the control group. CONCLUSION: The adjunctive use of probiotics with NSPT did not show any additional clinical effectiveness when compared to NSPT alone in the management of periodontitis (ChiCTR-IOR-17010526).
RCT Entities:
AIM: This study aimed to evaluate the clinical effectiveness of the probiotic Lactobacillus reuteri as an adjunct to non-surgical periodontal therapy (NSPT). MATERIALS AND METHODS: A double-blind, paralleled-arm, placebo-controlled and randomized clinical trial was conducted. Probiotics L. reuteri or placebo lozenges were randomly prescribed for use twice-daily for 28 days. Primary outcomes were clinical attachment levels (CAL) and probing pocket depths (PPD). All participants underwent NSPT, and follow-up clinical assessments were performed at day 90 and day 180. RESULTS: The trial response rate was 69.5% (41 out of 59). Among the test and control groups, there were significant intra-group differences in primary outcomes: CAL (both, p < .001) and PPD (both, p < .001); and in secondary outcomes: percentage of sites with 'bleeding on probing' (both, p < .001) and visible plaque (both, p < .001). There were no statistically significant inter-group differences in any outcomes at any time points (all, p > .05) nor in the changes in outcomes (∆) with time (all, p > .05). There was a trend of a greater magnitude of statistical change occurring among the test group compared to the control group. CONCLUSION: The adjunctive use of probiotics with NSPT did not show any additional clinical effectiveness when compared to NSPT alone in the management of periodontitis (ChiCTR-IOR-17010526).