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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02067572
Enrollment
88
Registered
2014-02-20
Start date
2014-03-12
Completion date
2016-09-08
Last updated
2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Terminal Illness, Xerostomia

Keywords

oral health, mouthwash, salvia, hospice, xerostomia, mouth sores

Brief summary

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.

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?

Interventions

OTHERSalvia mouthwash

Sponsors

University of Oslo
CollaboratorOTHER
Lovisenberg Diakonale Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oral health (OMAS)after 4 days of using mouthwashOral Mucositis Assessment Scale (OMAS)
Patient's perception of oral comfortafter 4 days of using mouthwashQuestions regarding oral discomfort and EORTC-OH17
Oral health (clinical evaluation)after 4 days of using mouthwashClinical evaluation by dentist

Secondary

MeasureTime frameDescription
General symptom experienceafter 4 days of using mouthwashEdmonton Symptom Assessment System (ESAS)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026