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A clinical trial of a novel emulsion for potential use as a saliva substitute in patients with radiation induced xerostomia
Accepted manuscript online:
have recently developed a novel oily formulation for potential use as a
saliva substitute for the treatment of dry mouth. The aim of this
randomised, cross-over study was to compare this new formulation to a
currently available saliva substitute and a control of water on measures
of mastication, subjective feeling of oral dryness and product
participants treated with radiotherapy to the head and neck and
experiencing xerostomia were invited to participate in the trial. Each
participant trialled all three products in a randomised order. The
effect of each product was measured using the Test of Masticating and
Swallowing Solids (TOMASS), the Shortened Xerostomia Inventory (SXI) and
a questionnaire designed to test patient acceptability of each product.
Outcome data were gathered in a single session after the first
administration of each product to evaluate immediate effects, and after
seven days of use to evaluate longer-term effects. Statistical analyses
consisted of repeated measures analysis of variance and mixed models.
was no evidence that application of the three formulations had an
effect on any of the TOMASS measures, either immediately or after one
week of use (p > 0.05). There was a significant main effect of
formulation on the SXI score (p=0.02). Application of the novel emulsion
resulted in a clinically small but significant improvement in SXI score
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novel oily emulsion showed no clinically significant benefit over two
existing products for relief of xerostomia. Indeed none of the three
products demonstrated significant change in patient outcomes.