Efficacy and Duration of Xerostomic Symptom-relief of a New Mouthgel

Objectives: To investigate the immediate efficacy after one-time application of the test product (Dr. Wolff Mouth Gel) versus a comparative product (Biotène) in relieving xerostomic burden, and to describe the duration of symptom-relief, taste and mucosal adhesion among xerostomia patients.
Methods: In this double-blind crossover pilot study, n=32 xerostomic patients were included and randomized into group 1 (phase 1 with test-gel Dr. Wolff Mouth Gel, Dr. Kurt Wolff GmbH & Co. KG, Bielefeld, Germany, n=16) and group 2 (phase 1 with comparator Biotène® Oralbalance, n=16). After use of the first product (phase 1), efficacy of symptom-relief, mucosal adhesion and persistence of taste were documented every 5 minutes over a 30-minutes-period. These endpoints were also described for the following washout-phase and the ensuing use of the second product (phase 2). Finally, subjective overall after-use assessment for each product was investigated after 30 minutes.
Results: Differences between test-gel and the commonly used water could be shown in favour of the test-gel for duration of symptom-relief (p<0.001), mucosal adhesion (p<0.001) and taste persistence (p<0.001). Differences between products could be shown for mucosal adhesion (p=0.024) in favour of the test-gel. Regarding subjective overall after-use assessment, effectiveness showed differences between water and test-gel (p=0.024), pleasance of taste showed differences between products (p=0.009), and the overall effect of a pleasant mouthfeel was different between water and test-gel (p=0.001) and between products (p=0.008), all in favour of test-gel.
Conclusions: Differences in perceived effectiveness and in-mouth duration regarding symptom-relief, mucosal adhesion and taste persistence could be shown between test-gel and water in favour of the test-gel. The overall after-use assessment 30 minutes after application gave better results of the test-gel compared to water in terms of effectiveness and pleasant mouthfeel. We conclude that the application of the newly-developed mouth gel can improve short-term xerostomic burden when compared to water.