Abstract
ObjectivesTo investigate plaque inhibition of 0.1% octenidine mouthwash (OCT) vs. placebo over 5 days in the absence of mechanical plaque control.Materials and methodsFor 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.ResultsTreatment 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.ConclusionsOCT 0.1% mouthwash inhibits plaque formation over 5 days. It therefore can be recommended when regular oral hygiene is temporarily compromised.Clinical relevanceWhen individual plaque control is compromised, rinsing with octenidine mouthwash is recommended to maintain healthy oral conditions while side effects are limited.
Highlights
Antiseptic mouthwashes are commonly used in oral home care
Because there were no statistically significant differences between the intention to treat and the per protocol analyses regarding any of the assessed variables, all results depicted in the following are based on the intention to treat analysis
Subjects of the octenidine mouthwash (OCT) group had a total median plaque index (PI) score of 0.36 after 5 days of OCT mouthwash use as the only personal oral hygiene measure compared to a median PI score of 1.29 in the placebo group
Summary
Antiseptic mouthwashes are commonly used in oral home care. They are recommended in situations where the performance of efficacious mechanical plaque control is temporarily or permanently impaired, like in individuals in need of care, after oral surgical interventions, during orthodontic therapy with fixed appliances or as adjunct for gingivitis or periodontitis therapy [1,2,3,4]. To a mandatory very low systemic cytotoxicity, antiseptic agents suitable for use in a mouthwash need to have a long-lasting substantivity. This prevents an agent to be washed out of the mouth immediately by the salivary flow. A broad, unspecific antibacterial efficacy towards all bacterial species colonizing the oropharynx is essential [5,6,7,8].
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