Satisfaction Clinical Trial
Official title:
Randomized Controlled Clinical Trial for Evaluating a Sage-based Mouthrinse in Regard to Its Anti-inflammatory Potential in Elderly Patients Which Are Dependent in Their ADLs
The investigators aim to evaluate a sage-based mouthrinse (Dr. Hauschka Med, Mundspülung
Salbei) whether it is less or equal effective in alleviating inflammatory signs of intra-oral
mucosa and gingiva than an water/alcohol-based taste adjusted placebo in patients dependent
on ADL.
Randomization in treatment A (mouthwash with active agent, n=24) or treatment B (placebo
mouthwash, n=24) Supervised use of mouthwash A or mouthwash B over 6 weeks 1x/day additional
to habitual oral hygiene protocol.
The main outcome parameter will be Sulcus Bleeding Index SBI.
A sage-based mouthrinse based on an extract from Salvia officinalis in a composition with
extracts from Althaea Officinalis, Aesculus Hippocatanum Bark and essential oils might
comprise an alternative to conventional antimicrobial mouthrinses, which might exhibit
important side effects. Thus the aim of the current study is to test the null-hypothesis H0:
A sage-based mouthrinse (Dr. Hauschka Med, Mundspülung Salbei, WALA Heilmittel GmbH,
Dorfstraße 1, 73087 Bad Boll/Eckwälden, Germany) is less or equal effective in alleviating
inflammatory signs of intra-oral mucosa and gingiva than an water/alcohol-based taste
adjusted placebo.
The placebo and the sage-based mouthrinse will be manufactured according to
EU-Kosmetik-Verordnung 1223/2009 and provided by WALA Heilmittel GmbH, Dorfstraße 1, 73087
Bad Boll/Eckwälden, Germany together with the necessary safety documentation. The placebo
will be an alcohol/ water based solution with a similar taste to the tested mouthrinse.
The main outcome parameter will be Sulcus Bleeding Index SBI. Among others, the main
secondary outcome parameters will be Oral Health Related Quality of Life as assessed with the
OHIP-14 G questionnaire, the Xerostomia inventory and a Tooth staining index.
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