Patients Satisfaction Survey and Total Antioxidant Capacity in Patients with Xerostomia Compared to a Placebo Group: An Evaluation of an Antioxidant Gel for Management of Xerostomia

Abstract

The aim of this study was to evaluate the clinical performance of an antioxidant (AO) gel used to treat patients suffering from drug-induced xerostomia compared to a placebo gel.

The study was a double-blind, prospective, randomized clinical trial. It included adult subjects with drug-induced xerostomia (n=43). Unstimulated whole salivary flow was measured using the spit technique. A Xerostomia Visual Analog Scale (XVAS) was used to assess symptoms of xerostomia and a patient satisfaction survey (PSS) to measure satisfaction with the gel. XVAS survey evaluations were performed at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 10 weeks. PSS evaluations were performed at 2 weeks, 4 weeks, 8 weeks, and 10 weeks. There was a crossover and wash out period from 4 to 6 weeks. Saliva was collected at each visit to measure Total Antioxidant Capacity (TAC).

43 patients were randomized into two groups, active or placebo. Symptoms improved in the treatment group (n=21) compared to the control group (n=15) after 10 weeks in the following PSS domains: Ability to eat, p<.05 at week 2, and Soothing effect, p<.05 at week 4. A significant difference was identified between the groups with the XVAS survey regarding the soothing effect after using the AO dry mouth gel (P<0.05). TAC analysis did not show any significant correlation with the use of gel. The topical application of an antioxidant gel containing phloretin and ferulic acid compared to a placebo improved symptoms of drug-induced xerostomia. However, no significant anti-oxidant effect was found using TAC analysis.