Clinical Trial for Evaluating Sage-Based Mouthrinse

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Stomal Bleeding, Stomatitis, Denture, Tooth Staining, Satisfaction

Intervention / Treatment
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* Other: Dr. Hauschka Med Mundspüllösung Salbei / cosmetics
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to give informed consent, i.e. no legal guardian appointed Willing to participate Depended on their ADLs (IADL)(24) Sulcus Bleeding Index (SBI) > 50% Exclusion Criteria: Allergy to one of the components Edentulous Alcohol dependency Prescription of antibiotics and/ or immunosuppressives (e.g. glucocorticoids) Anti-inflammatory mouthrinse -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Active Agent | Other: Dr. Hauschka Med Mundspüllösung Salbei / cosmetics<br>* Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol. For an application fill the closure cap with the mouthwash. Rinse the mouth vigorously for 30 seconds, for easier timekeeping use the hourglass. Then spit out the mouthwash, do not rinse.<br>|
| Placebo Comparator: Group B<br>Placebo | Other: Placebo<br>* Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol. For an application fill the closure cap with the mouthwash.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sulcus Bleeding Index |  | six weeks |