Clinical Trial for Evaluating Sage-Based Mouthrinse
Primary Purpose
Stomal Bleeding, Stomatitis, Denture, Tooth Staining
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Dr. Hauschka Med Mundspüllösung Salbei / cosmetics
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stomal Bleeding
Eligibility 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 -
Sites / Locations
- University of Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A
Group B
Arm Description
Active Agent
Placebo
Outcomes
Primary Outcome Measures
Sulcus Bleeding Index
Secondary Outcome Measures
Full Information
NCT ID
NCT02830802
First Posted
July 1, 2016
Last Updated
May 1, 2018
Sponsor
University of Bern
Collaborators
WALA Heilmittel GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02830802
Brief Title
Clinical Trial for Evaluating Sage-Based Mouthrinse
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 Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
WALA Heilmittel GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomal Bleeding, Stomatitis, Denture, Tooth Staining, Satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Active Agent
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Other
Intervention Name(s)
Dr. Hauschka Med Mundspüllösung Salbei / cosmetics
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol.
For an application fill the closure cap with the mouthwash.
Primary Outcome Measure Information:
Title
Sulcus Bleeding Index
Time Frame
six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schimmel, Prof.
Organizational Affiliation
University of Bern
Official's Role
Study Chair
Facility Information:
Facility Name
University of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial for Evaluating Sage-Based Mouthrinse
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