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

Abstract Objective This study aims to compare the effectiveness of 2 artificial saliva substitutes (Biotène vs HydraSmile) in the symptomatic management of radiation‐induced xerostomia. Study Design Randomized double‐blind cross‐over study. Setting Single tertiary care academic institution. Methods...

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Main Authors: Randall J. Harley, Eve Bowers, Jinhong Li, Mikayla Bisignani, Marci L. Nilsen, Jonas T. Johnson
Format: Article
Language:English
Published: Wiley 2025-01-01
Series:OTO Open
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Online Access:https://doi.org/10.1002/oto2.70038
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author Randall J. Harley
Eve Bowers
Jinhong Li
Mikayla Bisignani
Marci L. Nilsen
Jonas T. Johnson
author_facet Randall J. Harley
Eve Bowers
Jinhong Li
Mikayla Bisignani
Marci L. Nilsen
Jonas T. Johnson
author_sort Randall J. Harley
collection DOAJ
description Abstract Objective This study aims to compare the effectiveness of 2 artificial saliva substitutes (Biotène vs HydraSmile) in the symptomatic management of radiation‐induced xerostomia. Study Design Randomized double‐blind cross‐over study. Setting Single tertiary care academic institution. Methods Included adult patients ≥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 Biotène. 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 Biotène, with respect to baseline differences. Results A 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 Biotène (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 Biotène (mean difference 7.24, 95% CI 3.06‐11.43) significantly improved overall xerostomia score. Forty (44%) patients reported a preference for Biotène, 46 (50.5%) preferred HydraSmile, and 5 (5.5%) had no preference. Patients who preferred Biotène did not significantly benefit from HydraSmile, whereas those who preferred HydraSmile did not significantly benefit from Biotène. Conclusion Biotène 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.
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spelling doaj-art-aeec10c4d56e452c99b4a319dfc9f8c92025-08-20T02:48:41ZengWileyOTO Open2473-974X2025-01-0191n/an/a10.1002/oto2.70038Biotène Versus HydraSmile for Radiation‐Induced Xerostomia: Randomized Double‐Blind Cross‐Over StudyRandall J. Harley0Eve Bowers1Jinhong Li2Mikayla Bisignani3Marci L. Nilsen4Jonas T. Johnson5Department of Otorhinolaryngology–Head and Neck Surgery University of Pennsylvania Philadelphia Pennsylvania USADepartment of Otolaryngology–Head and Neck Surgery University of Miami Miller School of Medicine Miami Florida USADepartment of Biostatistics University of Pittsburgh, Graduate School of Public Health Pittsburgh Pennsylvania USADepartment of Otolaryngology–Head and Neck Surgery University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USADepartment of Otolaryngology–Head and Neck Surgery University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USADepartment of Otolaryngology–Head and Neck Surgery University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USAAbstract Objective This study aims to compare the effectiveness of 2 artificial saliva substitutes (Biotène vs HydraSmile) in the symptomatic management of radiation‐induced xerostomia. Study Design Randomized double‐blind cross‐over study. Setting Single tertiary care academic institution. Methods Included adult patients ≥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 Biotène. 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 Biotène, with respect to baseline differences. Results A 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 Biotène (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 Biotène (mean difference 7.24, 95% CI 3.06‐11.43) significantly improved overall xerostomia score. Forty (44%) patients reported a preference for Biotène, 46 (50.5%) preferred HydraSmile, and 5 (5.5%) had no preference. Patients who preferred Biotène did not significantly benefit from HydraSmile, whereas those who preferred HydraSmile did not significantly benefit from Biotène. Conclusion Biotène 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.https://doi.org/10.1002/oto2.70038artificial salivahead and neck cancerradiationxerostomia
spellingShingle Randall J. Harley
Eve Bowers
Jinhong Li
Mikayla Bisignani
Marci L. Nilsen
Jonas T. Johnson
Biotène Versus HydraSmile for Radiation‐Induced Xerostomia: Randomized Double‐Blind Cross‐Over Study
OTO Open
artificial saliva
head and neck cancer
radiation
xerostomia
title Biotène Versus HydraSmile for Radiation‐Induced Xerostomia: Randomized Double‐Blind Cross‐Over Study
title_full Biotène Versus HydraSmile for Radiation‐Induced Xerostomia: Randomized Double‐Blind Cross‐Over Study
title_fullStr Biotène Versus HydraSmile for Radiation‐Induced Xerostomia: Randomized Double‐Blind Cross‐Over Study
title_full_unstemmed Biotène Versus HydraSmile for Radiation‐Induced Xerostomia: Randomized Double‐Blind Cross‐Over Study
title_short Biotène Versus HydraSmile for Radiation‐Induced Xerostomia: Randomized Double‐Blind Cross‐Over Study
title_sort biotene versus hydrasmile for radiation induced xerostomia randomized double blind cross over study
topic artificial saliva
head and neck cancer
radiation
xerostomia
url https://doi.org/10.1002/oto2.70038
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AT mikaylabisignani bioteneversushydrasmileforradiationinducedxerostomiarandomizeddoubleblindcrossoverstudy
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