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Completed

NCT Number: NCT02830802

Clinical Trial for Evaluating Sage-Based Mouthrinse

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.

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Key information

Conditions

Stomal Bleeding Behavior Mouth Diseases Personal Satisfaction Satisfaction Stomatitis Stomatitis, Denture Stomatognathic Diseases Tooth Discoloration Tooth Diseases Tooth Staining

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Dr. Hauschka Med Mundspüllösung Salbei / cosmetics

Other

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

Other

Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol.

For an application fill the closure cap with the mouthwash.

Primary outcomes

  1. Sulcus Bleeding Index

    Time frame: six weeks

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • WALA Heilmittel GmbH

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 13, 2016
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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