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.
286 studies on the registry are indexed under Xerostomia; 51 are open to participants now.
This study's planned enrollment of 30 is below the median of 44 across 235 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →University of Bergen is the lead sponsor of 143 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients treated with radiotherapy in head and neck region.
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, Informed consent form
Time frame: Data will be available after publication of article.
No publications or documents are linked to this record.
Started Mar 2018 (actual). Primary completion is estimated for Dec 2018, 9 months after the start.
Of 85 non-industry interventional studies with no phase under Xerostomia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 33. This study's planned 9 months is below that.
Counting every sponsor, half of 101 studies reached it within 13 months; a quarter within 4 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.