Clinical Trial for Evaluating Sage-Based Mouthrinse

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)
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Martin Schimmel, Prof.	+4131 6322597	martin.schimmel@zmk.unibe.ch
Contact: Hendrik Juenger, Dr.	+4131 7477025

Locations

Switzerland
University of Bern	Recruiting
Bern, Switzerland, 3010
Contact: Martin Schimmel, Prof. +41316322597 martin.schimmel@zmk.unibe.ch

Sponsors and Collaborators

University of Bern

WALA Heilmittel GmbH

Investigators

Study Chair:	Martin Schimmel, Prof.	University of Bern

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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