Clinical Trial for Evaluating Sage-Based Mouthrinse

Satisfaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830802
• Other study ID #: gerodont_3: Sage Trial
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: April 2018

Study information

• Verified date: May 2018
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Satisfaction
• Stomal Bleeding
• Stomatitis
• Stomatitis, Denture
• Tooth Discoloration
• Tooth Staining

Intervention

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
Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol. For an application fill the closure cap with the mouthwash.

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	WALA Heilmittel GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sulcus Bleeding Index		six weeks