An interventional study of Glycerol 17% and Aequasyal (OGT) in Xerostomia, sponsored by University of Bergen. Status unknown at 1 site in Norway. Per ClinicalTrials.gov, last updated 2018-10-29.
Sponsored by University of Bergen · Not applicable, Interventional, and Supportive care
This study compares the effectiveness of 3 different oral moisturizers; 17% watery solution of glycerol, OGT oral spray, Aequasyal, and a newly developed Product, Salient.
Background:
A majority of patients in palliative care have problems with dry mouth caused by medication or as a direct result of the mortal condition. Dry mouth will cause a variety of problems that commonly affect the disease negatively and contribute to reduced quality of life in the patient's last stage of life. A Cochrane review from 2011 concludes that "there are several moisturising agents available, but no strong evidence that any topical therapy is effective for relieving the symptom of dry mouth." It also concludes that "Oxygenated glycerol triester (OGT) oral spray is more effective than an aqueous electrolyte spray."1
Objectives:
To compare the effectiveness of 3 different oral moisturisers, ; 17 % watery solution of glycerol, OGT oral spray, Aequasyal® and a newly developed product, Salient®.
Methods/design:
30 patients will be recruited from a Norwegian palliative care unit. Eligibility criteria for participants are:
Patients treated with radiotherapy in head and neck region, are excluded from this trial.
The different moisturizers will be compared in a double blind, cross-over design. All patients will be randomized to all three treatments in the cross-over trial, with a minimum of 24 hours wash-out period between the treatments. Patient responses will be collected at baseline, immediately after exposure and after 2 hours. Medical history and medication will be recorded. Primary outcome variables are the subjective feeling of xerostomia, pain/discomfort and speech disturbance.
Ethical considerations:
An application for approval of this study will be sent to the Regional Ethical Committee (REC). There are no known side effects of the agents or methods that will be applied.
Discussion:
To the investigators knowledge, the proposed randomized controlled trial of the effect of three different oral moisturizers will be the first study of this kind to be performed in patients in palliative institutionalized ward. There are no known adverse effects of the products used in this study.
Exclusion Criteria:
Patients treated with radiotherapy in head and neck region.
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Oral moisturizer
Device: Glycerol 17%
Oral moisturizer
Device: Aequasyal (OGT)
Oral moisturizer
Device: Salient (new product)
Glycerol will be applied, using gauze on a lockable tweezer, at the end of the oral care procedure performed by a dentist.
Aequasyl (OGT) will be sprayed on the mucosa, at the end of the oral care procedure, preformed by a dentist.
Salient (new Product) will be applied/given on a spoon, at the end of the oral care procedure, preformed by a dentist.
Subjective xerostomia
Measured on a 5-point Likert-scale: Subjective feeling of dry mouth: 1. Not dry 2. Insignificantly dry 3. Fairly dry 4. Almost completely dry 5. Completely dry
Time frame: 3 days
Pain/discomfort
Measured on a 5-point Likert-scale: Subjective feeling pain/discomfort: 1. No pain 2. Insignificant pain/discomfort 3. Some pain/discomfort 4. Much pain/discomfort 5. Strong pain/discomfort
Time frame: 3 days
Speech
Measured on a 5-point Likert-scale: Xerostomia regarding impact on ability to speak: 1. Not difficulties 2. Insignificant difficulties 3. Some difficulties 4. Significant difficulties 5. Major difficulties
Time frame: 3 days
Diurnal variation
Measured on a 5-point Likert-scale: At what times are xerostomia most pronounced: 1. At night 2. In the morning 3. In the afternoon 4. In the evening 5. No diurnal difference
Time frame: 3 days
Situational dry mouth
Measured on a 3-point Likert-scale: 1. By intake of medication 2. By worsening of the disease 3. In Connection with thirst
Time frame: 3 days
Plan to share: Yes — Anonymous data will be available by request after publication of effect article.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
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University of Bergen