The purpose of this three-month clinical trial was to evaluate the effects of a 0.1 % octenidine mouthrinse on plaque, gingivitis, extrinsic dental stain, and the oral soft tissues. A total of 451 adult volunteer subjects was initiated into the study and given baseline dental examinations. The subjects were stratified into two balanced groups according to gender, plaque, and gingivitis scores. The subjects then received a dental prophylaxis and were provided with dentifrice, toothbrushes, and either a mouth rinse containing 0.1 % octenidine dihydrochloride as the active ingredient or a similar placebo mouthrinse. Subjects were instructed to rinse with their assigned product for 30 s twice each day. Examinations were repeated at six weeks (soft-tissue assessment, gingivitis) and three months (soft tissues, plaque, gingivitis, dental stain). The results showed that the group rinsing with 0.1% octenidine had significantly less plaque (39%), gingivitis (50%), and bleeding sites (60%) than the group using the control product, but had significantly higher stain formation and experienced longer prophylaxis times to remove the stain. The oral soft-tissue examinations revealed no differences in the groups in either the numbers or types of lesions noted.
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