188 Chapter 9 consistency, and objections for specific ingredients. Investigating the opinion of the users at an early stage of the development of new saliva substitutes might provide tailored insights into preference criteria which may contribute to the development of more effective saliva substitutes. For this reason, the purpose of the current study was to explore the preferences of Sjögren’s syndrome patients for various product characteristics of potential new saliva substitutes, especially the important functions of possible substitutes, objections against certain ingredients, desired flavours for the substitutes, objections against potential side-effects of saliva substitutes, and the preferred method of administration. The unpleasant taste of saliva substitutes is a major reason for discontinuation of use of these products [11, 12]. Therefore, we explored the preferences for a wide range of possible flavours. As the amount of saliva present in the oral cavity may affect taste, we hypothesized that Sjögren’s syndrome patients with less severe dry-mouth experience will prefer different flavours than patients with more severe dryness. In addition, we hypothesized that Sjögren’s patients will have more objections against the presence of specific animal-based ingredients than for non-animal–based products. MATERIALS AND METHOD A cross-sectional study was performed among Sjögren’s syndrome patients who visited the website of the Dutch Sjögren Patients Federation (Dutch: Nederlandse Vereniging van Sjögren Patiënten). Volunteers could anonymously fill in the questionnaire described below during a period of 7 weeks. Only volunteers with diagnosed Sjogren’s syndrome were eligible to fill in the questionnaire. The local Ethics Review Committee of the Academic Centre for Dentistry Amsterdam (ACTA) confirmed that the Medical Research Involving Human Subjects Act (WMO) did not apply to this study (protocol number 2017001). The reporting of this study conforms to the Strengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement [15]. A priori sample size calculation was performed using G*Power software, version 3.1.9.4 (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany); with a medium effect size (0.5) and a power of 80%, 148 participants were needed.
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