Randomized Double-blind Placebo-controlled Study of Salivary Substitute With Enzimatic System for Xerostomia in Patient Irradiated in Head and Neck Region

Abstract

Abstract To compared whether the use of Bioxtra Spray® clinically reduces xerostomia intensity, impacting on the quality of life of patients who received radiotherapy in the head and neck region. A total of 40 patients were allocated in: Bioxtra Spray® group (n = 21) and Placebo arm (n = 19). Patients used both products three times a day for 30 days. For the analysis, xerostomia grade, unstimulated (UWS) and stimulated (SWS) salivary flow rate and quality of life through the University of Washington Quality of Life Questionnaire, validated in Portuguese (UW-QoL) were performed in two phases: Phase 1 (before the use of both products); Phase 2 (after 30 days of using both products). All clinical data were collected from medical records. Regarding salivary flow rate, it was observed that after 30 days of use, the Bioxtra Spray® group showed UWS and SWS significantly when compared to the Placebo arm (p < 0.05). Analyzing the Bioxtra Spray® Group, they showed improvement in xerostomia complaints compared to 30 days after using the product. Dispite this, we did not observed statistical differences (p > 0.05).Regarding quality of life, no significant differences were observed in relation to the UW-QoL saliva domain between the groups in the two phases of the study (p > 0.05). We concluded that Bioxtra Spray® may be effective in reducing radio-induced xerostomia symptoms. However, further research is necessary to evaluate the efficacy of BioXtra on oral health. Trial registration number: RBR-9sdf3k Date of trial registration submission: 10th June 2019