A preliminary report on patient acceptance of a novel intra-oral lubricating device for the management of radiotherapy-related xerostomia

Management of radiotherapy-related xerostomia is difficult. Saliva substitutes are helpful but the effects are short-lived. The purpose of the study was to develop a prototype intra-oral lubricating device for the management of radiotherapy-related xerostomia and to evaluate patient acceptance. An intra-oral lubricating device was fabricated that incorporated a reservoir in the palatal vault and permitted slow release of saliva substitute by the patient. Preliminary clinical testing was done in five patients with radiotherapy-related xerostomia. A measure incorporating seven questions was used to explore patient acceptance. The device was simple to fabricate using materials available in a technical laboratory. All patients were able to wear the device for at least 4 h per day throughout the test period. The device was considered easy to use and clean. Some impairment of speech and chewing was noted although this appeared to be related to the bulkiness of the reservoir. General oral comfort was improved due to the lubricating effect. The bulk of the reservoir was reduced as a consequence of patient feedback. The design addressed key problems associated with previous lubricating systems. Patient reports on oral functioning with the device in situ provided pivotal information on the device's utility.