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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
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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.
Karim, Naveen Manori (2017). 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. Master's thesis, Texas A & M University. Available electronically from