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Use of the Probiotic Limosilactobacillus reuteri as an Adjunct to Subgingival Instrumentation in the Treatment of Periodontitis Patients With Diabetes: A Randomised Clinical Trial.

  • 2025-09-17
  • Journal of clinical periodontology 53(1)
    • Rocío Bujaldón
    • Eduardo Montero
    • Juan Daniel Gamonal
    • Alejandro Abuelo
    • María José Marín
    • Margarita Iniesta
    • Mariano Sanz
    • David Herrera

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 40
Population
40 patients with untreated periodontitis and diabetes
Methods
6-month, randomised, triple-blinded clinical trial; patients received steps 1 and 2 of periodontal therapy including subgingival instrumentation, and were randomised to receive tablets containing L. reuteri or placebo for 3 months
Blinding
Triple-blind
Duration
6 months
Funding
Unclear

Aim

To evaluate the clinical and microbiological effects of a Limosilactobacillus reuteri-based probiotic as an adjunct to subgingival instrumentation in untreated periodontitis patients with diabetes.

Methods

A 6-month, randomised, triple-blinded clinical trial was conducted involving 40 patients, receiving steps 1 and 2 of periodontal therapy, including subgingival instrumentation, and randomised to receive tablets containing L. reuteri or placebo, for 3 months. Clinical and microbiological outcomes as well as glycosylated haemoglobin (HbA1c) concentrations were evaluated at baseline and at 3 and 6 months after therapy.

Results

At 6 months, both groups showed statistically significant reductions in the primary outcome (mean probing depth), with reductions of 0.9 mm in the probiotic group and 0.8 mm in the placebo group, with no significant differences between them. Both groups exhibited reductions in HbA1c levels after 6 months, more in the probiotic group (-0.6% vs. -0.1%), with statistically significant inter-group differences (-0.5%; 95% confidence interval [-1.0; 0.0]; p < 0.001). Microbiological outcomes were similar.

Conclusions

The adjunctive use of a L. reuteri-based probiotic did not provide additional clinical or microbiological benefits, compared to placebo, following subgingival instrumentation in patients with periodontitis and diabetes. However, statistically significant differences in HbA1c levels were observed, with larger reductions in the probiotic group, suggesting a potential systemic benefit.

Trial registration

The protocol was approved by the Clinical Research Ethics Committee (CEIC) of Hospital Clínico de San Carlos (internal code 19/101-R_X) and registered a priori in ClinicalTrials.gov (identifier NCT04069611).

Research Insights

  • Lactobacillus reuteri→Reduced Hemoglobin A1c

    Both groups exhibited reductions in HbA1c levels after 6 months, more in the probiotic group (-0.6% vs. -0.1%), with statistically significant inter-group differences (-0.5%; 95% confidence interval [-1.0; 0.0]; p < 0.001).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    tablets containing L. reuteri for 3 months (exact dose not specified in abstract)
  • Lactobacillus reuteri→Reduced Microbiological Pathogen Count

    Microbiological outcomes were similar.

    Effect
    Neutral
    Effect size
    Small
    Dose
    tablets containing L. reuteri for 3 months (exact dose not specified in abstract)
  • Lactobacillus reuteri→Reduced Probing Depth

    At 6 months, both groups showed statistically significant reductions in the primary outcome (mean probing depth), with reductions of 0.9 mm in the probiotic group and 0.8 mm in the placebo group, with no significant differences between them.

    Effect
    Neutral
    Effect size
    Small
    Dose
    tablets containing L. reuteri for 3 months (exact dose not specified in abstract)
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