title: Safety and effectiveness of topical dry mouth products containing olive oil, betaine, and xylitol in reducing xerostomia for polypharmacy-induced dry mouth.
abstract: Polypharmacy is a common cause of salivary hypofunction, producing symptoms of dry mouth or xerostomia, especially among older populations. As the number of older people continues to increase, polypharmacy-induced salivary hypofunction is becoming an increasing problem. Many over-the-counter products are available for relieving symptoms of dry mouth, but few have been tested in controlled clinical investigations. The purpose of this investigation was to evaluate the safety and efficacy of a group of topical dry mouth products (toothpaste, mouth rinse, mouth spray and gel) containing olive oil, betaine and xylitol. Forty adults were entered into this single-blinded, open-label, cross-over clinical study and 39 completed all the visits. Subjects were randomly assigned at baseline to using the novel topical dry mouth products daily for 1 week, or to maintain their normal dry mouth routine care. After 1 week, they were crossed over to the other dry mouth regimen. The results demonstrated that the use of the novel topical dry mouth products increased significantly unstimulated whole salivary flow rates, reduced complaints of xerostomia and improved xerostomia-associated quality of life. No clinically significant adverse events were observed. These data suggest that the daily use of topical dry mouth products containing olive oil, betaine and xylitol is safe and effective in relieving symptoms of dry mouth in a population with polypharmacy-induced xerostomia.
authors.affiliation: Department of Oral & Maxillofacial Pathology, Radiology, and Medicine, New York University College of Dentistry and the Bluestone Center for Clinical Research, New York, NY, USA. jonathan.ship@nyu.edu
authors.forename: J A
authors.initials: JA
authors.lastname: Ship
authors.forename: J A
authors.initials: JA
authors.lastname: McCutcheon
authors.forename: S
authors.initials: S
authors.lastname: Spivakovsky
authors.forename: A R
authors.initials: AR
authors.lastname: Kerr
mesh_terms: D000368:Aged; D001622:Betaine / Q000627:therapeutic use; D018592:Cross-Over Studies; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes; D000069463:Olive Oil; D010938:Plant Oils / Q000627:therapeutic use; D019338:Polypharmacy; D011788:Quality of Life; D012720:Severity of Illness Index; D016037:Single-Blind Method; D014100:Toothpastes; D016896:Treatment Outcome; D014987:Xerostomia / Q000139:chemically induced / Q000188:drug therapy*; D014993:Xylitol / Q000627:therapeutic use