The objective of this clinical trial is to identify the most efficacious octenidine dihydrochloride concentration regarding bacterial count reduction in comparison to a placebo in the oral cavity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden
Dresden, Germany
Abteilung für Parodontologie in der Poliklinik für Zahnerhaltung und Parodontologie der Universität Würzburg
Würzburg, Germany
Bacterial count reduction in saliva after a single application of OML in comparison to placebo application
Bacterial count reduction is measured at V1 (Verum/Placebo) and V3 (Placebo/Verum) in a blinded cross-over design
Time frame: After 1 minute of rinsing
Mean plaque index (PI)
PI is measured at V2 (Verum/Placebo) and V4 (Placebo/Verum) in a blinded cross-over design
Time frame: After 5 days of application
Change in mean gingival index (GI)
GI is measured at V1/V2 (Verum/Placebo) and V3/V4 (Placebo/Verum) in a blinded cross-over design
Time frame: After 5 days of application
Evaluation of taste and flavour (questionnaire)
Time frame: After 5 days of application
AEs and SAEs
Time frame: 4 weeks
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