Dataset Information

Impact of 0.1% octenidine mouthwash on plaque re-growth in healthy adults: a multi-center phase 3 randomized clinical trial.

ABSTRACT:

Objectives

To investigate plaque inhibition of 0.1% octenidine mouthwash (OCT) vs. placebo over 5 days in the absence of mechanical plaque control.

Materials and methods

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.

Results

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.

Conclusions

OCT 0.1% mouthwash inhibits plaque formation over 5 days. It therefore can be recommended when regular oral hygiene is temporarily compromised.

Clinical relevance

When individual plaque control is compromised, rinsing with octenidine mouthwash is recommended to maintain healthy oral conditions while side effects are limited.

SUBMITTER: Jockel-Schneider Y

PROVIDER: S-EPMC8310509 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Publications

Impact of 0.1% octenidine mouthwash on plaque re-growth in healthy adults: a multi-center phase 3 randomized clinical trial.

Jockel-Schneider Yvonne Y Schlagenhauf Ulrich U Petsos Hari H Rüttermann Stefan S Schmidt Jana J Ziebolz Dirk D Wehner Christian C Laky Markus M Rott Thea T Noack Michael M Noack Barbara B Lorenz Katrin K

Clinical oral investigations 20210122 7

<h4>Objectives</h4>To investigate plaque inhibition of 0.1% octenidine mouthwash (OCT) vs. placebo over 5 days in the absence of mechanical plaque control.<h4>Materials and methods</h4>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 mout ...[more]

PMID: 33483868

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Project description:ObjectiveOctenidine dihydrochloride is an antimicrobial cationic surfactant compound. We conducted a systematic review to determine the efficacy of octenidine-based mouthwash on plaque formation, gingivitis, and oral microbial growth in subjects with or without periodontal disease.Materials and methodsPubMed/MEDLINE, ScienceDirect, Google Scholar, and Cochrane Library were searched for relevant studies. The review was conducted per PRISMA guidelines. Only randomized controlled trials and observational studies comparing octenidine with placebo or other mouthwashes in healthy subjects with or without periodontal disease, were considered for this review. The endpoints included percentage reduction in plaque index (PI), gingival index (GI), absolute reduction in the mean number of colony-forming units (CFU/ml [log10 ]) and adverse effects (AEs; tooth staining/mucosal tolerance).ResultsTen randomized controlled and six observational studies fulfilled the selection criteria. Twice or thrice daily rinsing with 0.1% octenidine for 30-60 s produced significant reduction in plaque, gingivitis and oral microbial growth. Compared to control mouthwash or baseline, 0.1% octenidine inhibited plaque formation by ~38.7%-92.9%, which was either equal or greater than that of chlorhexidine gluconate. 0.1% octenidine reduced gingivitis by ~36.4%-68.37% versus control mouthwash or baseline and microbial growth by 0.37-5.3 colony-forming units (vs. chlorhexidine: 0.4-4.23 colony-forming units). Additional benefits of 0.1% octenidine were significant reduction in the number of bleeding sites, papilla bleeding index, sulcus bleeding index, and gingival fluid flow.ConclusionWithin the limitations of this study, there exists moderate evidence that 0.1% OCT was found to be an effective antiplaque agent. Octenidine inhibited plaque formation upto 93% and gingivitis upto 68% versus placebo and was either superior or comparable to chlorhexidine. Octenidine was well-tolerated and safe and can be an effective alternative to CHX and other contemporary mouthwashes.

Project description:BackgroundThe effect of cymenol mouthwashes on levels of dental plaque has not been evaluated thus far.ObjectiveTo analyse the short-term, in situ, anti-plaque effect of a 0.1% cymenol mouthwash using the DenTiUS Deep Plaque software.MethodsFifty orally healthy participants were distributed randomly into two groups: 24 received a cymenol mouthwash for eight days (test group A) and 26 a placebo mouthwash for four days and a cymenol mouthwash for a further four days thereafter (test group B). They were instructed not to perform other oral hygiene measures. On days 0, 4, and 8 of the experiment, a rinsing protocol for staining the dental plaque with sodium fluorescein was performed. Three intraoral photographs were taken per subject under ultraviolet light. The 504 images were analysed using the DenTiUS Deep Plaque software, and visible and total plaque indices were calculated (ClinicalTrials ID NCT05521230).ResultsOn day 4, the percentage area of visible plaque was significantly lower in test group A than in test group B (absolute = 35.31 ± 14.93% vs. 46.57 ± 18.92%, p = 0.023; relative = 29.80 ± 13.97% vs. 40.53 ± 18.48%, p = 0.024). In comparison with the placebo, the cymenol mouthwash was found to have reduced the growth rate of the area of visible plaque in the first four days by 26% (absolute) to 28% (relative). On day 8, the percentage areas of both the visible and total plaque were significantly lower in test group A than in test group B (visible absolute = 44.79 ± 15.77% vs. 65.12 ± 16.37%, p < 0.001; visible relative = 39.27 ± 14.33% vs. 59.24 ± 16.90%, p < 0.001; total = 65.17 ± 9.73% vs. 74.52 ± 13.55%, p = 0.007). Accounting for the growth rate with the placebo mouthwash on day 4, the above results imply that the cymenol mouthwash in the last four days of the trial reduced the growth rate of the area of visible plaque (absolute and relative) by 53% (test group A) and 29% (test group B), and of the area of total plaque by 48% (test group A) and 41% (test group B).ConclusionsThe 0.1% cymenol mouthwash has a short-term anti-plaque effect in situ, strongly conditioning the rate of plaque growth, even in clinical situations with high levels of dental plaque accumulation.

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Dataset Information

Impact of 0.1% octenidine mouthwash on plaque re-growth in healthy adults: a multi-center phase 3 randomized clinical trial.

Objectives

Materials and methods

Results

Conclusions

Clinical relevance

Publications

Impact of 0.1% octenidine mouthwash on plaque re-growth in healthy adults: a multi-center phase 3 randomized clinical trial.

Similar Datasets

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