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

Lovisenberg Diakonale Hospital

Status: Completed

Conditions: Terminal Illness; Xerostomia

Treatments: Other: Salvia mouthwash; Other: Saline mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT02067572

Salvia

Details and patient eligibility

About

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.

Full 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?

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

Salvia

Experimental group

Description:

Salvia mouthwash used 4 times per day for 4 days

Treatment:

Other: Salvia mouthwash

Saline

Active Comparator group

Description:

Saline mouthwash used 4 times per day for 4 days.

Treatment:

Other: Saline mouthwash