IADR Abstract Archives
Efficacy of GUM Hydral® Versus Biotène® Oralbalance on Medication-induced Xerostomia
Objectives: To determine the efficacy of the investigational product GUM® Hydral Mouth wash and Gel and the comparator product Biotène® Oralbalance Mouth wash and Gel on the subjective burden and objective clinical symptoms among patients with medication-induced xerostomia.
Methods: N=40 participants (mean age (SD) 58 (16.6) years) with medication-induced dry mouth (minimum 4 on a 10 mm VAS scale) were included in this randomized double-blind crossover trial investigating the efficacy of a 28-day-use of GUM Hydral® versus Biotène® Oralbalance mouthwash and gel with a 21-day wash-out period. VAS-Scales (A), OHIPG-14 (B), Xerostomia Questionnaire (XQ)(C), subjective after-use questionnaire (D) and clinical parameters (E) were explored.
Results: After 28-day-use of GUM Hydral®, a reduction (p<0.05) of VAS, OHIPG-14 Total Score and single items, XQ Part1 (Oral dryness, Oral pain, Taste loss, Dysphagia), and XQ Part 2 items as well as the clinical parameter Halitosis organoleptic score (p=0.059) could be determined; after use of Biotène® Oralbalance, a reduction (p<0.05) of VAS, OHIPG-14 Total Score and single items, XQ Part1 (Oral dryness, Oral Pain, Taste loss), XQ Part 2 items, and clinical parameters (halitosis organoleptic score and PI) could be determined. The saliva amount showed an increase but not of clinical relevance. No difference between treatment groups besides the OHIPG-14-items “Uncertainty“ and “Trouble pronouncing words“ could be determined. No adverse effects like allergies, mucositis or intolerancies were reported.
Conclusions: The use of GUM Hydral® and Biotène® Oralbalance was effective particularly appearing in the oral health and xerostomia related quality of life. The continuous in-mouth secretion of saliva cannot be completely substituted and patients rather report a relief for certain time-spans. The decision on the selection of one of the products subject to this study will be based on subjective differences such as taste, subjective retention time and personal sensation.
Patients with medication-induced xerostomia can be informed of these available treatment options since no adverse effects could be detected.
These symptom-relieving products are beneficial regarding the patients’ xerostomic burden and should be part of the treatment concept.
Methods: N=40 participants (mean age (SD) 58 (16.6) years) with medication-induced dry mouth (minimum 4 on a 10 mm VAS scale) were included in this randomized double-blind crossover trial investigating the efficacy of a 28-day-use of GUM Hydral® versus Biotène® Oralbalance mouthwash and gel with a 21-day wash-out period. VAS-Scales (A), OHIPG-14 (B), Xerostomia Questionnaire (XQ)(C), subjective after-use questionnaire (D) and clinical parameters (E) were explored.
Results: After 28-day-use of GUM Hydral®, a reduction (p<0.05) of VAS, OHIPG-14 Total Score and single items, XQ Part1 (Oral dryness, Oral pain, Taste loss, Dysphagia), and XQ Part 2 items as well as the clinical parameter Halitosis organoleptic score (p=0.059) could be determined; after use of Biotène® Oralbalance, a reduction (p<0.05) of VAS, OHIPG-14 Total Score and single items, XQ Part1 (Oral dryness, Oral Pain, Taste loss), XQ Part 2 items, and clinical parameters (halitosis organoleptic score and PI) could be determined. The saliva amount showed an increase but not of clinical relevance. No difference between treatment groups besides the OHIPG-14-items “Uncertainty“ and “Trouble pronouncing words“ could be determined. No adverse effects like allergies, mucositis or intolerancies were reported.
Conclusions: The use of GUM Hydral® and Biotène® Oralbalance was effective particularly appearing in the oral health and xerostomia related quality of life. The continuous in-mouth secretion of saliva cannot be completely substituted and patients rather report a relief for certain time-spans. The decision on the selection of one of the products subject to this study will be based on subjective differences such as taste, subjective retention time and personal sensation.
Patients with medication-induced xerostomia can be informed of these available treatment options since no adverse effects could be detected.
These symptom-relieving products are beneficial regarding the patients’ xerostomic burden and should be part of the treatment concept.