Altamura Serena, Lombardi Francesca, Augello Francesca Rosaria, Barone Antonella, Giannoni Mario, Cinque Benedetta, Pietropaoli Davide
Department of Life, Health & Environmental Sciences, University of L'Aquila, Building Rita Levi Montalcini, Coppito, L'Aquila, 67100, Italy.
PhD School in Medicine and Public Health, University of L'Aquila, L'Aquila, Italy.
J Transl Med. 2025 Jan 28;23(1):128. doi: 10.1186/s12967-024-06000-1.
A growing number of in vitro and in vivo studies suggest the application of probiotics as a natural approach to maintaining oral health. This double-blind, randomized controlled trial aimed to evaluate the efficacy of Levilactobacillus brevis CD2 (CNCM I-5566), a multifunctional probiotic frequently used in oral medicine, in preserving or improving several recognized oral health indicators.
Thirty consenting healthy adults were randomized to receive four lozenges per day of L. brevis CD2 probiotic (n = 15) or placebo (n = 15) over four weeks. Clinical parameters (full-mouth bleeding on probing (BoP) and plaque index (PI) scores) were recorded. Unstimulated saliva was collected to measure salivation rate, pH, and buffer capacity. Salivary biomarkers were analyzed, including glucose, D-lactate, and secretory immunoglobulins A (sIgA). Clinical and salivary parameters were assessed at baseline, after four weeks of intervention, and two weeks post-intervention. Wilcoxon rank-sum test and robust regression analysis were used for statistical comparisons. The possible mediating effect of PI on BoP changes was assessed.
After four weeks, the probiotic group showed significant improvements in BoP and PI compared to baseline and placebo. The probiotic group had a higher salivation rate than baseline and placebo after four weeks of treatment and washout. While changes in salivary pH were not significant, buffering capacity increased in the probiotic group after four weeks of treatment and washout. Salivary glucose and D-lactate levels were lower in the probiotic group post-treatment and after washout. sIgA values increased and remained stable after washout in the probiotic group. No adverse effects were reported.
The treatment with L. brevis CD2 significantly improved clinical and salivary parameters, supporting its efficacy as a probiotic for oral health.
ClinicalTrials.gov , NCT06457724; Registered 7 June 2024 - Retrospectively registered; https://clinicaltrials.gov/study/NCT06457724?viewType=Table&page=452&rank=4512#study-overview .
越来越多的体外和体内研究表明，应用益生菌是维持口腔健康的一种自然方法。这项双盲、随机对照试验旨在评估短双歧杆菌CD2（保藏编号为CNCM I-5566）（一种口腔医学中常用的多功能益生菌）在保持或改善多项公认的口腔健康指标方面的疗效。
30名同意参与的健康成年人被随机分为两组，在四周内，一组每天服用4片短双歧杆菌CD2益生菌含片（n = 15），另一组每天服用4片安慰剂（n = 15）。记录临床参数（探诊时全口出血（BoP）和菌斑指数（PI）评分）。收集非刺激性唾液以测量唾液分泌率、pH值和缓冲能力。分析唾液生物标志物，包括葡萄糖、D-乳酸和分泌型免疫球蛋白A（sIgA）。在基线、干预四周后和干预后两周评估临床和唾液参数。采用Wilcoxon秩和检验和稳健回归分析进行统计比较。评估PI对BoP变化的可能中介作用。
四周后，与基线和安慰剂组相比，益生菌组的BoP和PI有显著改善。治疗四周和洗脱期后，益生菌组的唾液分泌率高于基线和安慰剂组。虽然唾液pH值的变化不显著，但治疗四周和洗脱期后，益生菌组的缓冲能力增加。治疗后和洗脱期后，益生菌组的唾液葡萄糖和D-乳酸水平较低。益生菌组的sIgA值在洗脱期后增加并保持稳定。未报告不良反应。
短双歧杆菌CD2治疗显著改善了临床和唾液参数，支持其作为口腔健康益生菌的疗效。
ClinicalTrials.gov，NCT06457724；2024年6月7日注册——追溯注册；https://clinicaltrials.gov/study/NCT06457724?viewType=Table&page=452&rank=4512#study-overview 。
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