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

February 17, 2017 updated by: Lovisenberg Diakonale Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

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

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0440
        • Lovisenberg Hospice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Salvia
Salvia mouthwash used 4 times per day for 4 days
Other: Salvia mouthwash
ACTIVE_COMPARATOR: Saline
Saline mouthwash used 4 times per day for 4 days.
Other: Saline mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral health (OMAS)
Time Frame: after 4 days of using mouthwash
Oral Mucositis Assessment Scale (OMAS)
after 4 days of using mouthwash
Patient's perception of oral comfort
Time Frame: after 4 days of using mouthwash
Questions regarding oral discomfort and EORTC-OH17
after 4 days of using mouthwash
Oral health (clinical evaluation)
Time Frame: after 4 days of using mouthwash
Clinical evaluation by dentist
after 4 days of using mouthwash

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General symptom experience
Time Frame: after 4 days of using mouthwash
Edmonton Symptom Assessment System (ESAS)
after 4 days of using mouthwash

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lovisenberg Diakonale Hospital

Collaborators

University of Oslo

Investigators

  • Principal Investigator: Anners Lerdal, PhD, Lovisenberg Diakonale Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 12, 2014

Primary Completion (ACTUAL)

September 8, 2016

Study Completion (ACTUAL)

September 8, 2016

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (ESTIMATE)

February 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Salvia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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