Sparabombe Scilla, Monterubbianesi Riccardo, Tosco Vincenzo, Orilisi Giulia, Hosein Andrell, Ferrante Luigi, Putignano Angelo, Orsini Giovanna
Department of Clinical Sciences and Stomatology, Marche Polytechnic University, Ancona, Italy.
Department of Clinical and Molecular Sciences, Marche Polytechnic University, Ancona, Italy.
Front Physiol. 2019 May 22;10:632. doi: 10.3389/fphys.2019.00632. eCollection 2019.
This study aimed to evaluate the anti-inflammatory effect and the incidence of adverse effects of an all-natural polyherbal mouthwash in patients with periodontitis, after 3 months of use. These aims were accomplished by using full mouth bleeding score (FMBS), full mouth plaque score (FMPS), probing depth (PD) clinical attachment level (CAL) and a questionnaire recording any adverse events. The present randomized controlled clinical study considered 40 patients with moderate or severe periodontitis, randomized in two groups: a test group (TG) and a control group (CG). TG was instructed to use a polyherbal mouthwash composed of resin extract, leaves extract, and 1.75% of essential oils and the CG was given a placebo mouthwash. Both groups were instructed to rinse for 2 min, twice daily after their routine oral home care with the different mouthwashes. Clinical measurements of FMBS, FMPS, PD and CAL were recorded at baseline (T0) and after 3 months (T1). The incidence of adverse outcomes was recorded at every follow-up. Mann-Whitney U test and Wilcoxon signed-rank test were used for the statistical analysis ( < 0.05). The final study sample consisted of 34 healthy individuals, 17 individuals in each of the two groups. TG and CG showed a statistically significant reduction in FMBS ( = 0.001 TG; = 0.002 CG), FMPS ( = 0.001 TG; = 0.003 CG), PD ( = 0.001 TG; = 0.011 CG) and CAL ( < 0.001 TG; = 0.020 CG) values from baseline to 3 months. The TG showed a statistically significant decrease in FMBS and FMPS compared with the CG. No adverse events or side effects were reported or observed in both groups. The use of polyherbal mouthwash in patients with moderate or severe periodontitis has proved safe and effective in reducing bleeding score and plaque accumulation, after 3 months, compared with placebo, although no difference between the two groups were reported on PD and CAL (both improving at T1).
本研究旨在评估一种全天然多草药漱口水在牙周炎患者使用3个月后的抗炎效果及不良反应发生率。这些目标是通过使用全口出血评分(FMBS)、全口菌斑评分(FMPS)、探诊深度(PD)、临床附着水平(CAL)以及记录任何不良事件的问卷来实现的。本随机对照临床研究纳入了40例中度或重度牙周炎患者,随机分为两组:试验组(TG)和对照组(CG)。试验组被指导使用一种由树脂提取物、树叶提取物和1.75%精油组成的多草药漱口水,对照组则使用安慰剂漱口水。两组均被指导在日常口腔家庭护理后,用不同的漱口水每天漱口两次,每次2分钟。在基线(T0)和3个月后(T1)记录FMBS、FMPS、PD和CAL的临床测量值。在每次随访时记录不良结局的发生率。采用曼-惠特尼U检验和威尔科克森符号秩检验进行统计分析(P<0.05)。最终研究样本包括34名健康个体,两组各17名。试验组和对照组从基线到3个月时,FMBS(试验组P = 0.001;对照组P = 0.002)、FMPS(试验组P = 0.001;对照组P = 0.003)、PD(试验组P = 0.001;对照组P = 0.011)和CAL(试验组P<0.001;对照组P = 0.020)值均有统计学意义的降低。试验组与对照组相比,FMBS和FMPS有统计学意义的下降。两组均未报告或观察到不良事件或副作用。与安慰剂相比,在中度或重度牙周炎患者中使用多草药漱口水3个月后,在降低出血评分和菌斑堆积方面已证明是安全有效的,尽管两组在PD和CAL方面未报告差异(两者在T1时均有改善)。