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

Xerostomia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067572
• Other study ID #: Salvia
• Status: Completed
• Phase: N/A
• First received: February 18, 2014
• Last updated: February 17, 2017
• Start date: March 12, 2014
• Est. completion date: September 8, 2016

Study information

• Verified date: February 2017
• Source: Lovisenberg Diakonale Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 8, 2016
• Est. primary completion date: September 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Terminal Illness
• Xerostomia

Intervention

Other:
• Saline mouthwash

• Salvia mouthwash

Locations

Country	Name	City	State
Norway	Lovisenberg Hospice	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Lovisenberg Diakonale Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral health (OMAS)	Oral Mucositis Assessment Scale (OMAS)	after 4 days of using mouthwash
Primary	Patient's perception of oral comfort	Questions regarding oral discomfort and EORTC-OH17	after 4 days of using mouthwash
Primary	Oral health (clinical evaluation)	Clinical evaluation by dentist	after 4 days of using mouthwash
Secondary	General symptom experience	Edmonton Symptom Assessment System (ESAS)	after 4 days of using mouthwash