Efficacy of biotene and xerostom on salivary function, biomarkers, and caries risk in radiation-induced xerostomia: A randomized controlled trial.

Abstract

Background: Radiation-induced xerostomia is a common complication in head and neck cancer (HNC) patients, significantly impairing oral health, nutrition, and quality of life. Salivary substitutes such as Biotene and Xerostom have been developed to manage symptoms, but clinical evidence comparing their effectiveness is limited.

Aim: The aim is to evaluate and compare the efficacy of Biotene and Xerostom salivary systems in improving salivary properties and reducing caries susceptibility in postradiotherapy (RT) HNC patients.

Methods: Sixty-six patients with radiation-induced xerostomia were randomly assigned to three groups: Biotene (n = 22), Xerostom (n = 22), and placebo (n = 22). Interventions were used for 28 days. Salivary flow rate, pH, buffering capacity, mucin-7 (MUC7), β-defensin-2, Streptococcus mutans count, and oral mucositis (OM) were assessed at baseline, 1, 3, and 6 months. Data were analyzed using repeated measures analysis of variance and Chi-square tests.

Results: Both Biotene and Xerostom significantly improved salivary flow (Biotene: 1.26 ± 0.22 mL/min; Xerostom: 1.00 ± 0.25 mL/min) compared to placebo (0.76 ± 0.27 mL/min) at 6 months. pH and buffering capacity also improved in both intervention groups. MUC7 levels were higher in Biotene (77.71 ± 9.38 ng/mL) and Xerostom (74.92 ± 6.76 ng/mL) compared to placebo (61.48 ± 4.96 ng/mL), indicating enhanced mucosal protection. β-defensin-2 levels were lower in treatment groups, suggesting balanced immune activity. S. mutans counts were significantly reduced in Biotene (9.20 ± 8.50 CFU/mL) and Xerostom (12.5 ± 12.82 CFU/mL) versus placebo (118.75 ± 60.61 CFU/mL), reflecting reduced caries risk. OM severity was also lower in treated groups.

Conclusion: Both Biotene and Xerostom improved salivary function, reduced microbial load, and enhanced oral mucosal protection in HNC patients with radiation-induced xerostomia. Biotene demonstrated marginally superior outcomes. These systems may serve as effective interventions for xerostomia management post-RT.