Clinical Trial for Evaluating Sage-Based Mouthrinse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

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

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


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

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

Primary Outcome Measures :

Sulcus Bleeding Index [ Time Frame: six weeks ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Switzerland
University of Bern
Bern, Switzerland, 3010

Sponsors and Collaborators

University of Bern

WALA Heilmittel GmbH

Investigators


Study Chair:	Martin Schimmel, Prof.	University of Bern

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 Key Record Dates
Last Update Posted:	May 2, 2018
Last Verified:	May 2018
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

To Top