Department of Periodontology, University Hospital Wuerzburg, Pleicherwall 2, 97070, Wuerzburg, Germany.
Department of Periodontology, Johann Wolfgang Goethe-Universität Frankfurt am Main, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany.
Clin Oral Investig. 2021 Jul;25(7):4681-4689. doi: 10.1007/s00784-021-03781-3. Epub 2021 Jan 22.
To investigate plaque inhibition of 0.1% octenidine mouthwash (OCT) vs. placebo over 5 days in the absence of mechanical plaque control.
For this randomized, placebo-controlled, double-blind, parallel group, multi-center phase 3 study, 201 healthy adults were recruited. After baseline recording of plaque index (PI) and gingival index (GI), collection of salivary samples, and dental prophylaxis, subjects were randomly assigned to OCT or placebo mouthwash in a 3:1 ratio. Rinsing was performed twice daily for 30 s. Colony forming units in saliva were determined before and after the first rinse. At day 5, PI, GI, and tooth discoloration index (DI) were assessed. Non-parametric van Elteren tests were applied with a significance level of p < 0.05.
Treatment with OCT inhibited plaque formation more than treatment with placebo (PI: 0.36 vs. 1.29; p < 0.0001). OCT reduced GI (0.04 vs. placebo 0.00; p = 0.003) and salivary bacterial counts (2.73 vs. placebo 0.24 lgCFU/ml; p < 0.0001). Tooth discoloration was slightly higher under OCT (DI: 0.25 vs. placebo 0.00; p = 0.0011). Mild tongue staining and dysgeusia occurred.
OCT 0.1% mouthwash inhibits plaque formation over 5 days. It therefore can be recommended when regular oral hygiene is temporarily compromised.
When individual plaque control is compromised, rinsing with octenidine mouthwash is recommended to maintain healthy oral conditions while side effects are limited.
在无机械菌斑控制的情况下，研究 0.1%奥替尼啶漱口水（OCT）与安慰剂相比对菌斑的抑制作用，为期 5 天。
这是一项随机、安慰剂对照、双盲、平行分组、多中心的 3 期研究，共招募了 201 名健康成年人。在基线记录菌斑指数（PI）和牙龈指数（GI）、唾液样本采集和牙齿洁治后，将受试者按 3:1 的比例随机分配到 OCT 或安慰剂漱口液组。每天漱口两次，每次 30 秒。在第一次漱口前后，检测唾液中的菌落形成单位。第 5 天，评估 PI、GI 和牙齿变色指数（DI）。采用非参数 van Elteren 检验，p 值<0.05。
OCT 治疗组的菌斑形成明显少于安慰剂组（PI：0.36 比 1.29；p<0.0001）。OCT 降低了 GI（0.04 比安慰剂 0.00；p=0.003）和唾液细菌计数（2.73 比安慰剂 0.24 lgCFU/ml；p<0.0001）。OCT 组的牙齿变色略高（DI：0.25 比安慰剂 0.00；p=0.0011）。轻度舌染色和味觉障碍。
OCT 0.1%漱口水可抑制菌斑形成 5 天。因此，当常规口腔卫生暂时受到影响时，可以推荐使用。
当个体菌斑控制受到影响时，建议使用奥替尼啶漱口水冲洗，以维持口腔健康，同时副作用有限。
