Clinical Trial for Evaluating Sage-Based Mouthrinse

Not Applicable

Completed

• Conditions: Stomal Bleeding; Stomatitis, Denture; Satisfaction; Tooth Staining
• Interventions: Other: Dr. Hauschka Med Mundspüllösung Salbei / cosmetics; Other: Placebo

• Registration Number: NCT02830802
• Lead Sponsor: University of Bern

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.

Study Timeline

• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Study Start: 2016-10
• Primary Completion: 2017-10
• Study Completion: 2018-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Dr. Hauschka Med Mundspüllösung Salbei / cosmetics	Active Agent
Group B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Sulcus Bleeding Index	six weeks

Trial Locations

Locations (1)

University of Bern; 🇨🇭 Bern, Switzerland