Clinical Trial for Evaluating Sage-Based Mouthrinse
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
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedMay 2, 2018
May 1, 2018
1 year
July 1, 2016
May 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Sulcus Bleeding Index
six weeks
Study Arms (2)
Group A
EXPERIMENTALActive Agent
Group B
PLACEBO COMPARATORPlacebo
Interventions
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.
Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol. For an application fill the closure cap with the mouthwash.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- Allergy to one of the components
- Edentulous
- Alcohol dependency
- Prescription of antibiotics and/ or immunosuppressives (e.g. glucocorticoids) Anti-inflammatory mouthrinse -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bernlead
- WALA Heilmittel GmbHcollaborator
Study Sites (1)
University of Bern
Bern, 3010, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Martin Schimmel, Prof.
University of Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2016
First Posted
July 13, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2017
Study Completion
April 1, 2018
Last Updated
May 2, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share