TY  - JOUR
A1  - Jockel-Schneider, Yvonne
A1  - Schlagenhauf, Ulrich
A1  - Petsos, Hari
A1  - Rüttermann, Stefan
A1  - Schmidt, Jana
A1  - Ziebolz, Dirk
A1  - Wehner, Christian
A1  - Laky, Markus
A1  - Rott, Thea
A1  - Noack, Michael
A1  - Noack, Barbara
A1  - Lorenz, Katrin
T1  - Impact of 0.1% octenidine mouthwash on plaque re-growth in healthy adults: a multi-center phase 3 randomized clinical trial
JF  - Clinical Oral Investigations
N2  - 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.
KW  - octenidine
KW  - mouthrinse
KW  - bacterial counts
KW  - plaque index
KW  - gingival index
KW  - discoloration index
Y1  - 2021
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-307629
SN  - 1432-6981
SN  - 1436-3771
VL  - 25
IS  - 7
ER  -