Efficacy of a newly developed mouth gel for xerostomia relief-A randomized double-blind trial.

OBJECTIVES: To determine the efficacy of a new symptom-relieving mouth gel vs. a widely used control gel on xerostomic burden. MATERIALS AND METHODS: This randomized, double-blind, crossover trial investigated the efficacy of the test gel (Dr. Wolff Gel) vs. control (Biotene) in participants with xerostomia (n = 32; mean age 60 years). Oral examinations were taken at baseline, and xerostomic visual analogue scales (xVAS), after-use questionnaires and willingness to pay were investigated before and after use. RESULTS: Neither gel reduced xerostomic burden (xVAS) after 7-day application. There was some preference for the test gel regarding taste and healthy gum feeling. After 1-time application, there were differences favouring the test gel for symptom-relieving effects between test gel and water (p < 0.001), mucosal adhesion (p < 0.001) and taste persistence (p < 0.001). Overall symptomatic relief with the test gel lasted around 2 hr. CONCLUSIONS: No mouth gel alleviated the overall xerostomic burden. Nevertheless, the test gel led to short-term perceived symptomatic relief and improved patient-centred outcomes as taste and perceived gum health. The gel will probably mainly be effective at moments that patients mostly suffer from xerostomia. Selection of a product will be based on perceived subjective differences and their value in the context of the overall xerostomic burden.