Efficacy of Two Different Mouth Gels Developed for Xerostomia Relief

Objectives: To determine the efficacy of the investigational hydroxyapatite-containing symptom-relieving mouth gel (Dr. Wolff mouth gel) versus Biotène Gel as control on subjective burden of xerostomic symptoms among patients with xerostomia.

Methods: N=32 participants (mean age 60 (±13) years) with xerostomia (10 cm VAS scale) were included in this randomized double-blind crossover trial investigating the efficacy of a 7-day-use of the test product (Dr. Kurt Wolff GmbH & Co. KG, Bielefeld, Germany) versus Biotène (GlaxoSmithKline) as control with a 7-day wash-out period. Dental examinations were taken at baseline; xerostomic VAS-Scales, after-use questionnaires, and willingness-to-pay (bidding game with starting point at 10€) were investigated before and after use.

Results: After 7-day-use no differences between both products could be shown (p=0.489) as well as no reduction (p=0.220) of the xerostomic VAS scales. Differences between products could be shown in favour of the test gel regarding taste (p=0.042) and feeling of healthy gums (p=0.065). Symptom relief was reported for 91 (±82) minutes after application of Dr. Wolff gel. Burning tongue was reported after its use among n=2 participants with radiation history, no other side effects occurred.

Conclusions: 7-day-use of the test mouth gel could not alleviate general xerostomic burden measured by VAS Scales without differences to the control gel. However, the overall perceived symptomatic relief lasted 1.5 hours and patient-centred secondary outcomes such as taste and perceived gum health either showed no difference or favourable results towards Dr. Wolff mouth gel. We therefore conclude that patients can be informed of these available treatment options while the decision on the selection of one of these products will mainly be based on these perceived subjective differences and the perception of patients how valuable the perceived relief is in the context of the overall xerostomic burden.