Biotène Versus HydraSmile for Radiation-Induced Xerostomia: Randomized Double-Blind Cross-Over Study

ObjectiveThis study aims to compare the effectiveness of 2 artificial saliva substitutes (Biot & egrave;ne vs HydraSmile) in the symptomatic management of radiation-induced xerostomia.Study DesignRandomized double-blind cross-over study.SettingSingle tertiary care academic institution.MethodsIncluded adult patients >= $<!--<semantics>-->\ge <!--</semantics>-->$6 months postradiotherapy (50-70 gy) for squamous cell carcinoma of the oral cavity, oropharynx, or larynx. The primary endpoint was change in overall subjective xerostomia score from baseline, through use of HydraSmile versus Biot & egrave;ne. Scores were derived from a 100-point visual analog scale, with higher scores indicating better symptomatic control. Analysis of covariance model was used to regress the difference in after-treatment measurement between HydraSmile and Biot & egrave;ne, with respect to baseline differences.ResultsA total of 91 participants were included (mean age 63.0 years [SD 9.7]; 85.7% male; 97.8% White). Change in overall xerostomia score with respect to baseline was not significantly different between HydraSmile and Biot & egrave;ne (mean difference 1.24, 95% confidence interval [CI] -2.35 to 4.81). Compared to water alone, both HydraSmile (mean difference 7.45, 95% CI 3.61-11.29) and Biot & egrave;ne (mean difference 7.24, 95% CI 3.06-11.43) significantly improved overall xerostomia score. Forty (44%) patients reported a preference for Biot & egrave;ne, 46 (50.5%) preferred HydraSmile, and 5 (5.5%) had no preference. Patients who preferred Biot & egrave;ne did not significantly benefit from HydraSmile, whereas those who preferred HydraSmile did not significantly benefit from Biot & egrave;ne.ConclusionBiot & egrave;ne and HydraSmile significantly improved oral dryness among patients with radiation-induced xerostomia. While neither product demonstrated treatment superiority, individual product preference was predictive of greatest treatment benefit.