Anna Greta Barbe1, Lena Ludwar1, Stefanie Hamacher2, Michael Johannes Noack1. 1. Centre of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne, Köln, Germany. 2. Faculty of Medicine, Institute of Medical Statistics and Computational Biology, University Hospital Cologne, University of Cologne, Köln, Germany.
Abstract
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.
RCT Entities:
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.