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NCT Number: NCT02067572

A Randomized Controlled Trial Evaluating the Effectiveness of a Salvia-based Mouthwash in Palliative Care

This study examines the effectiveness of an herbal mouthwash made from salvia in maintaining good oral health among patients in palliative care. It is hypothesized that using the mouthwash made from salvia will result in better oral health and more oral comfort than using with conventional normal saline mouthwash.

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Key information

Conditions

Terminal Illness Mouth Diseases Oral Ulcer Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lovisenberg Hospice

Oslo, 0440, Norway

About this study

The aim of this study is to examine the effectiveness of an herbal mouthwash made from salvia officinalis (SO) in maintaining good oral health among patients in palliative care. The study compares a mouthwash based on salvia tea solution with conventional normal saline mouthwash and addresses the following research questions:

  • Does the SO-based mouthwash provide a better treatment than conventional normal saline in maintaining good oral health in terminally ill patients?
  • Is there a difference in the individual perception of oral comfort in patients receiving SO versus patients receiving saline rinsing solution?

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Attending bedded unit at Hospice
  • Over 18 years of age and able to provide written formal consent
  • Diagnosed with advanced cancer
  • Patient with positive response when asked if they experience oral discomfort or complications.

Exclusion criteria

  • Estimated life expectancy prognosis of less than 2 weeks
  • Significant cognitive impairment
  • Current use of antifungal medication
  • Currently receiving radiation therapy or chemotherapy
  • Epileptic
  • Diabetic

Treatment and study plan

Saline mouthwash

Other

Salvia mouthwash

Other

Primary outcomes

  1. Oral health (OMAS)

    Time frame: after 4 days of using mouthwash

    Oral Mucositis Assessment Scale (OMAS)

  2. Patient's perception of oral comfort

    Time frame: after 4 days of using mouthwash

    Questions regarding oral discomfort and EORTC-OH17

  3. Oral health (clinical evaluation)

    Time frame: after 4 days of using mouthwash

    Clinical evaluation by dentist

Secondary outcomes

  1. General symptom experience

    Time frame: after 4 days of using mouthwash

    Edmonton Symptom Assessment System (ESAS)

Sponsors and collaborators

Lead sponsor

Lovisenberg Diakonale Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

A Comparison of the Effectiveness of Normal Saline Mouthwash and Mouthwash Based on Tea Solution From Salvia Officinalis (SO) in Palliative Care. A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2014
Registry last updated
Feb 20, 2017

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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