目的:为了评估ε-聚-L-赖氨酸(ε-PL)组合的抗菌效果,真菌肽(FP)以及抗口腔病原体的domiphen,并在临床试验中评估补充有该组合的BOP®漱口水在减少口臭和牙龈上斑块中的功效。
方法:化合物对核梭杆菌的最低抑菌浓度(MIC)和最低杀菌浓度(MBC),牙龈卟啉单胞菌,变形链球菌,用梯度稀释法测定放线菌和总菌放线菌。随后,CCK-8法检测漱口水对人牙龈成纤维细胞的毒性,并通过随机分析了补充该组合的漱口水减少口臭和牙龈上斑块的有效性,双盲,平行对照临床试验。
结果:该组合对所测试的口腔病原体具有显着的抑制作用,MIC<1.56%(v/v)和MBC<3.13%(v/v),并且含有该组合的漱口水在测试浓度下不抑制人牙龈成纤维细胞的活力。临床试验表明,试验组在0、10、24h时表现出明显较低的挥发性硫化合物(VSCs),漱口水后7d(P<0.05),与基线相比。7天后,对照组和对照组的VSC水平分别降低了50.27%和32.12%,分别,显着减少了57.03%的测试组严重口臭。此外,试验组和对照组的菌斑指数(PLI)分别下降了54.55%和8.38%,分别,7天后两组PLI差异有统计学意义(P<0.01)。
结论:ε-PL的组合,FP和domiphen对测试的口腔病原体表现出有效的抑制和杀菌作用,与该组合一起添加的新配方漱口水在临床试验中表现出抗牙菌斑和抗口臭特性,并且是安全的。
背景:随机对照临床试验已在中国临床试验注册中心注册(编号:ChiCTR2300073816,日期:21/07/2023)。
OBJECTIVE: To evaluate the antibacterial effectiveness of a combination of ε-poly-L-lysine (ε-PL), funme peptide (FP) as well as domiphen against oral pathogens, and assess the efficacy of a BOP® mouthwash supplemented with this combination in reducing halitosis and supragingival plaque in a clinical trial.
METHODS: The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of the compound against Fusobacterium nucleatum, Porphyromonas gingivalis, Streptococcus mutans, and Aggregatibacter actinomycetemcomitans were determined by the gradient dilution method. Subsequently, the CCK-8 assay was used to detect the toxicity of mouthwash on human gingival fibroblastst, and the effectiveness in reducing halitosis and supragingival plaque of the mouthwash supplemented with the combination was analyzed by a randomized, double-blind, parallel-controlled clinical trial.
RESULTS: The combination exhibited significant inhibitory effects on tested oral pathogens with the MIC < 1.56% (v/v) and the MBC < 3.13% (v/v), and the mouthwash containing this combination did not inhibit the viability of human gingival fibroblasts at the test concentrations. The clinical trial showed that the test group displayed notably lower volatile sulfur compounds (VSCs) at 0, 10, 24 h, and 7 d post-mouthwash (P < 0.05), compared with the baseline. After 7 days, the VSC levels of the and control groups were reduced by 50.27% and 32.12%, respectively, and notably cutting severe halitosis by 57.03% in the test group. Additionally, the Plaque Index (PLI) of the test and control group decreased by 54.55% and 8.38%, respectively, and there was a significant difference in PLI between the two groups after 7 days (P < 0.01).
CONCLUSIONS: The combination of ε-PL, FP and domiphen demonstrated potent inhibitory and bactericidal effects against the tested oral pathogens, and the newly formulated mouthwash added with the combination exhibited anti-dental plaque and anti-halitosis properties in a clinical trial and was safe.
BACKGROUND: The randomized controlled clinical trial was registered on Chinese Clinical Trial Registry (No. ChiCTR2300073816, Date: 21/07/2023).