The objective of the study is to demonstrate the superiority of 0.1% octenidine mouthwash (Octenidin Mundspüllösung, OML) to placebo (PLAC) in the inhibition of plaque formation. The study will consist of a 14-day screening period and a 5-day treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
Poliklinik für Parodontologie der Johann Wolfgang Goethe Universität Frankfurt am Main
Frankfurt am Main, Hesse, Germany
Poliklinik für Parodontologie der Med. Fakultät C. G. Carus der TU Dresden
Dresden, Saxony, Germany
Poliklinik für Zahnerhaltung und Parodontologie am Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Total mean PI (Plaque index according to Silness and Löe) after 5 days of treatment at Visit 2
The total mean PI is the sum of the individual scores divided by the number of investigated sites. The thickness and extension of plaque along the gingival margin will be assessed.
Time frame: after 5 days of treatment
Bacterial count reduction in saliva after a single administration of OML vs placebo
Bacterial count in saliva will be assessed prior to the first administration of study medication and 1 min after the first administration
Time frame: after 1 minute of rinsing
Change in total mean GI (Gingival Index according to Löe, 1967) from Visit 1 to Visit 2
The total mean GI is the sum of the individual scores divided by the number of investigated sites. The GI for each tooth is the sum of the 4 individual scores divided by 4.
Time frame: baseline and after 5 days of treatment
Incidence and severity of AEs (adverse events)
Time frame: 5 days
Incidence of SAEs (serious adverse events)
Time frame: 15 days
Change in tooth discoloration index from Visit 1 to Visit 2
Time frame: baseline and after 5 days of treatment
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