Octenidinedihydrochlorid
DrugMouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
Other names: 0.1% Octenidine Mouthwash, OML
NCT Number: NCT03378401
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.
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Notify Me18 year–99 year
All sexes
Interventional
Phase 3
Universitätszahnklinik Wien, Fachbereich Zahnerhaltung und Parodontologie, Vienna, Austria
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
Other names: 0.1% Octenidine Mouthwash, OML
Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
Time frame: after 5 days of treatment
The total mean PI is the sum of the individual scores divided by the number of investigated sites.
Time frame: after 1 minute of rinsing
Bacterial count in saliva will be assessed prior to the first administration of study medication and 1 min after the first administration
Time frame: baseline and after 5 days of treatment
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: 5 days
Time frame: 15 days
Time frame: baseline and after 5 days of treatment
Schülke & Mayr GmbH
Industry
Randomized, Placebo-controlled, Parallel Group, Double-blind, Multi-center Phase III Study to Assess the Inhibition of Plaque Formation of 0.1% Octenidine Mouthwash vs Placebo in Subjects With a Gingival Index ≤1.5
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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Inhibition of Plaque Formation (by Gingivitis-Index ≤1.5)
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View Trial Details