Efficacy of a novel lubricating system in the management of radiotherapy-related xerostomia.

A comparison was made of Oral Balance gel delivered by slow release via a novel intra-oral device versus an oral bolus of gel on the oral health condition and oral health-related quality of life (OHRQoL) in patients who had received standard head and neck irradiation for nasopharyngeal carcinoma. Twenty-two participants took part in a randomized single-blind crossover clinical study. Each treatment lasted 4 weeks with an intervening 4 weeks washout period. The GOHAI, Xerostomia Inventory and patient satisfaction measures were self-completed and oral health condition assessed objectively at baseline (week 0) and weeks 4, 8 and 12. Oral Balance gel, in bolus and slow-release forms, was effective in improving aspects of oral health, notably a reduction in oral cariogenic micro-organisms. Slow release of gel via the intra-oral device did not appear to improve OHRQoL whereas gel alone reduced the severity of xerostomia symptoms and was the treatment of choice.

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.