Abstract：
In this prospective pilot study, 84 patients with a history of poor oral hygiene were enrolled in an open-label, interventional, randomized controlled clinical trial. The aim was to provide preliminary clinical data on a new line of oral hygiene products containing a prebiotic and a paraprobiotic based on Lactobacillus plantarum. The recruitment rate and patient satisfaction were analyzed to estimate resources for the future primary study, and descriptive data on rebalancing of the oral microbiota were collected. The population was divided into 5 groups based on the products assigned to the patients: 1, delicate mint toothpaste (n = 20); 2, mint toothpaste (n = 12); 3, mint mouthwash (n = 20); 4, delicate mint toothpaste, mint mouthwash, and an antimicrobial toothbrush (n = 20); and 5, continued use of their usual oral care products and routine (control group; n = 12). The study duration was 28 days. All patients tolerated the products well, and there were no adverse events. The recruitment capability and procedures allowed for a realistic estimation for the future main trial. The products did not cause any changes in tooth color. The participants in group 4, who completed the treatment consisting of delicate mint toothpaste, mint mouthwash, and an antimicrobial toothbrush, reported the greatest reduction in gingival sensitivity (P ≤ 0.000; Wilcoxon signed rank test). Analysis with the Wilcoxon signed rank test revealed that all products induced a statistically significant decrease in plaque (P ≤ 0.002) and a reduction in gingival sensitivity (delicate mint toothpaste, P ≤ 0.005; mint toothpaste, P ≤ 0.015; and mint mouthwash, P ≤ 0.015). All products were effective in stabilizing the oral microbiota. The tested products showed an optimal safety profile and a statistically significant efficacy in reducing gingival sensitivity and plaque. They also stabilized the biodiversity of the oral microbiota, making it less susceptible to microbial fluctuations than the control group. Trial registration: ClinicalTrials.gov (NCT05999175).
摘要：
在这项前瞻性试点研究中，84名口腔卫生不良史的患者被纳入开放标签，介入,随机对照临床试验。目的是提供有关包含基于植物乳杆菌的益生元和副益生菌的新型口腔卫生产品系列的初步临床数据。对招募率和患者满意度进行了分析，以估计未来主要研究的资源，收集口腔微生物群再平衡的描述性数据。根据分配给患者的产品将人群分为5组：1，精致薄荷牙膏（n=20）;2，薄荷牙膏（n=12）;3，薄荷漱口水（n=20）;4，精致薄荷牙膏，薄荷漱口水,和抗菌牙刷（n=20）；和5，继续使用其常规口腔护理产品和常规（对照组；n=12）。研究持续时间为28天。所有患者对产品耐受性良好，并且没有不良事件。招募能力和程序允许对未来的主要审判进行现实的估计。产品没有引起牙齿颜色的任何变化。第4组的参与者完成了由精致的薄荷牙膏组成的治疗，薄荷漱口水,和一个抗菌牙刷,报告牙龈敏感性降低最大（P≤0.000；Wilcoxon符号秩检验）。Wilcoxon符号秩检验分析显示，所有产品均导致牙菌斑的统计学显着减少（P≤0.002）和牙龈敏感性降低（精致的薄荷牙膏，P≤0.005；薄荷牙膏，P≤0.015；和薄荷漱口水，P≤0.015)。所有产品均有效稳定口腔微生物群。所测试的产品在减少牙龈敏感性和牙菌斑方面显示出最佳的安全性和统计学上显著的功效。他们还稳定了口腔微生物群的生物多样性，使其比对照组更不容易受到微生物波动的影响。试用注册：ClinicalTrials.gov（NCT05999175）。
