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Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 30
Population
Sixty patients with plaque-induced generalized gingivitis
Methods
Double-blind, randomized, placebo-controlled clinical trial; sixty patients were submitted to professional supragingival scaling and prophylaxis and randomly assigned to test (probiotic lozenges containing B. lactis HN019, n = 30) or control (placebo lozenges, n = 30) groups; lozenges were consumed twice a day for 8 weeks

Objectives

This double-blind, randomized, placebo-controlled clinical trial evaluated the adjuvant effects of Bifidobacterium lactis HN019 on the treatment of plaque-induced generalized gingivitis.

Materials and methods

Sixty patients were submitted to professional supragingival scaling and prophylaxis. They were randomly assigned to test (probiotic lozenges containing B. lactis HN019, n = 30) or control (placebo lozenges, n = 30) groups. Lozenges were consumed twice a day for 8 weeks. Bleeding on probing (BoP), Gingival Index (GI), Plaque Index (PI), probing depth (PD), and clinical attachment level (CAL) were evaluated at baseline and after 2 and 8 weeks. Gingival crevicular fluid (GCF) was collected at baseline and at 8 weeks for analysis of the inflammatory mediators IL-1β, IL-1α, IL-8, MCP-1, and MIP-1β. Data were statistically analyzed (p < 0.05).

Results

After 8 weeks, both groups showed reduction in the percentage of PI, with no significant difference between groups (p = 0.7423). The test group presented a lower percentage of BoP and a higher percentage of sites with GI ≤ 1 when compared with the control group at the end of the study (p < 0.0001). At 8 weeks, the test group had a greater number of patients without generalized gingivitis than the control group (20 and 11 patients, respectively; p < 0.05). The test group presented significantly lower levels of IL-1α, IL-1β, and MCP-1 in GCF than the control group at the end of the study (p < 0.05).

Conclusion

The adjunct use of B. lactis HN019 promotes additional clinical and immunological benefits in the treatment of generalized gingivitis.

Clinical relevance

B. lactis HN019 can be an efficient and side-effect-free adjunct strategy in the treatment of generalized gingivitis.

Research Insights

SupplementDoseHealth OutcomeEffect TypeEffect SizeSource
Bifidobacterium animalis subsp. lactis HN019Improved Gingival HealthBeneficial
Moderate
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The test group presented a lower percentage of BoP and a higher percentage of sites with GI ≤ 1 when compared with the control group at the end of the study (p < 0.0001). At 8 weeks, the test group had a greater number of patients without generalized gingivitis than the control group (20 and 11 patients, respectively; p < 0.05).

Bifidobacterium animalis subsp. lactis HN019Reduced Formation of Dental PlaqueNeutral
Small
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After 8 weeks, both groups showed reduction in the percentage of PI, with no significant difference between groups (p = 0.7423).

Bifidobacterium animalis subsp. lactis HN019Reduced Gingival InflammationBeneficial
Moderate
View source

The test group presented significantly lower levels of IL-1α, IL-1β, and MCP-1 in GCF than the control group at the end of the study (p < 0.05).

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