Clinical Trial for Evaluating Sage-Based Mouthrinse
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ClinicalTrials.gov Identifier: NCT02830802 |
Recruitment Status
:
Recruiting
First Posted
: July 13, 2016
Last Update Posted
: May 10, 2017
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stomal Bleeding Stomatitis, Denture Tooth Staining Satisfaction | Other: Dr. Hauschka Med Mundspüllösung Salbei / cosmetics Other: Placebo | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | October 2016 |
Estimated Primary Completion Date : | October 2017 |
Estimated Study Completion Date : | April 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Group A
Active Agent
|
Other: Dr. Hauschka Med Mundspüllösung Salbei / cosmetics
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. |
Placebo Comparator: Group B
Placebo
|
Other: Placebo
Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol. For an application fill the closure cap with the mouthwash. |
- Sulcus Bleeding Index [ Time Frame: six weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 -

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830802
Contact: Martin Schimmel, Prof. | +4131 6322597 | martin.schimmel@zmk.unibe.ch | |
Contact: Hendrik Juenger, Dr. | +4131 7477025 |
Switzerland | |
University of Bern | Recruiting |
Bern, Switzerland, 3010 | |
Contact: Martin Schimmel, Prof. +41316322597 martin.schimmel@zmk.unibe.ch |
Study Chair: | Martin Schimmel, Prof. | University of Bern |
Responsible Party: | University of Bern |
ClinicalTrials.gov Identifier: | NCT02830802 History of Changes |
Other Study ID Numbers: |
gerodont_3: Sage Trial |
First Posted: | July 13, 2016 Key Record Dates |
Last Update Posted: | May 10, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Stomatitis Tooth Discoloration Stomatitis, Denture |
Mouth Diseases Stomatognathic Diseases Tooth Diseases |