Journal of clinical periodontology · 2025
Use of the Probiotic Limosilactobacillus reuteri as an Adjunct to Subgingival Instrumentation in the Treatment of Periodontitis Patients With Diabetes: A Randomised Clinical Trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Bujaldón Rocío, Montero Eduardo, Gamonal Juan Daniel, Abuelo Alejandro, Marín María José, Iniesta Margarita, Sanz Mariano, Herrera David
Аннотация
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).
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).