title: Evaluation of the efficacy of a topical sialogogue spray containing malic acid 1% in elderly people with xerostomia: a double-blind, randomized clinical trial.
abstract: OBJECTIVE
  The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid for elderly people affected by xerostomia.
  
  
  METHODS
  This research took the form of a double-blind, randomized clinical trial. Forty-one individuals (mean age: 78.7 years) with xerostomia were divided into two groups: for the first 'intervention group' (21 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second 'control group' (20 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The Xerostomia Inventory (XI) was used to evaluate xerostomia levels before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after spray application, were measured.
  
  
  RESULTS
  XI scores decreased significantly (clinically meaningful) from 36.4 ± 7.3 points to 29.1 ± 7.1 (p < 0.05) with an XI difference of 7.2 ± 6.1, after the combination among 1% malic acid with xylitol and fluoride application. After 2 weeks of 1% malic acid application, unstimulated and stimulated salivary flows rates increased significantly (p < 0.05).
  
  
  CONCLUSIONS
  A topical sialogogue spray containing 1% malic acid improved xerostomia in an elderly population and increased unstimulated and stimulated salivary flows rates.
authors.affiliation: Department of Special Care and Pharmacological Research in Dentistry, Faculty of Dentistry, University of Granada, Granada, Spain.
authors.forename: Gerardo
authors.initials: G
authors.lastname: Gómez-Moreno
authors.forename: Maribel
authors.initials: M
authors.lastname: Cabrera-Ayala
authors.forename: Antonio
authors.initials: A
authors.lastname: Aguilar-Salvatierra
authors.forename: Javier
authors.initials: J
authors.lastname: Guardia
authors.forename: María Piedad
authors.initials: MP
authors.lastname: Ramírez-Fernández
authors.forename: Maximino
authors.initials: M
authors.lastname: González-Jaranay
authors.forename: José Luis
authors.initials: JL
authors.lastname: Calvo-Guirado
mesh_terms: D000284:Administration, Oral; D000336:Aerosols; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005459:Fluorides / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D008293:Malates / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D010919:Placebos; D012463:Saliva / Q000187:drug effects / Q000378:metabolism; D012464:Saliva, Artificial / Q000008:administration & dosage / Q000627:therapeutic use*; D012636:Secretory Rate / Q000187:drug effects; D016896:Treatment Outcome; D014987:Xerostomia / Q000145:classification / Q000188:drug therapy*; D014993:Xylitol / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D000336:Aerosols; D008293:Malates; D010919:Placebos; D012464:Saliva, Artificial; C030298:malic acid; D005459:Fluorides; D014993:Xylitol
keywords: drug; elderly; hyposialia; malic acid; xerostomia