title: Efficacy of GUM® Hydral versus Biotène® Oralbalance mouthwashes plus gels on symptoms of medication-induced xerostomia: a randomized, double-blind, crossover study.
abstract: OBJECTIVE
  The objective of this study is to determine the efficacy of GUM® Hydral versus Biotène® Oralbalance (both a mouthwash plus gel) on the subjective burden and clinical symptoms of patients with medication-induced xerostomia.
  
  
  METHODS
  Subjects (N = 40) with medication-induced xerostomia (minimum 4/10 mm visual analog scale [VAS]) were randomized to treatment with GUM Hydral or Biotène Oralbalance mouthwash, both with gel, for 28 days. Subjects then entered a 21-day wash-out period, before crossing over to the other treatment for 28 days. Outcomes measured included the VAS, German Oral Health Impact Profile (OHIPG)-14, Xerostomia Questionnaire (XQ), after-use questionnaire, and clinical parameters.
  
  
  RESULTS
  Both GUM Hydral and Biotène Oralbalance significantly (p < 0.05) reduced VAS, OHIPG-14 total score and single items, and XQ Part 1 (oral dryness, oral pain, taste loss) and Part 2 items. GUM Hydral also significantly reduced the XQ Part 1 dysphagia score, while Biotène Oralbalance significantly reduced the halitosis organoleptic score and plaque index. Significant increases in saliva secretion did not reach clinical relevance. No significant between-group differences were observed, apart from OHIPG-14 items "trouble pronouncing words" and "uncertainty" in favor of GUM Hydral. No adverse effects were reported.
  
  
  CONCLUSIONS
  Both products effectively improve oral health and xerostomia-related quality of life. However, they cannot completely substitute the continuous in-mouth secretion of saliva, and symptomatic relief is temporary. Product selection will be based on personal preference.
  
  
  CONCLUSIONS
  Both products diminish xerostomic burden and should be part of the management strategy. Affected patients should be informed of these treatments, since no adverse effects were reported.
authors.affiliation: Centre of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Köln, Germany. anna.barbe@uk-koeln.de.
authors.forename: Anna Greta
authors.initials: AG
authors.lastname: Barbe
authors.affiliation: Centre of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Köln, Germany.
authors.forename: Yasmin
authors.initials: Y
authors.lastname: Schmidt-Park
authors.affiliation: Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, 50924, Köln, Germany.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Hamacher
authors.affiliation: Centre of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Köln, Germany.
authors.forename: Sonja Henny Maria
authors.initials: SHM
authors.lastname: Derman
authors.affiliation: Centre of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Köln, Germany.
authors.forename: Michael Johannes
authors.initials: MJ
authors.lastname: Noack
mesh_terms: D000284:Administration, Oral; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005782:Gels; D005949:Glucose Oxidase / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007784:Lactoperoxidase / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D009113:Muramidase / Q000008:administration & dosage / Q000627:therapeutic use*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D014987:Xerostomia / Q000139:chemically induced* / Q000188:drug therapy*
chemical_list: C111669:Biotene; D004338:Drug Combinations; D005782:Gels; D009067:Mouthwashes; D005949:Glucose Oxidase; D007784:Lactoperoxidase; D009113:Muramidase
keywords: Gel; Medication-induced xerostomia; Mouthwash; Oral health-related quality of life; Xerostomia questionnaire; Xerostomic burden