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Clinical Trial for Evaluating Sage-Based Mouthrinse

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ClinicalTrials.gov Identifier: NCT02830802
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
WALA Heilmittel GmbH
Information provided by (Responsible Party):
University of Bern

Study Description
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Brief Summary:

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

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 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
Actual Primary Completion Date : October 2017
Actual Study Completion Date : April 2018
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Sulcus Bleeding Index [ Time Frame: six weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Switzerland
University of Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
WALA Heilmittel GmbH
Investigators
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Study Chair: Martin Schimmel, Prof. University of Bern
More Information
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02830802    
Other Study ID Numbers: gerodont_3: Sage Trial
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomatitis
Stomatitis, Denture
Mouth Diseases
Stomatognathic Diseases