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.

MATERIAL AND 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).

CONCLUSION:

A topical sialogogue spray containing 1% malic acid improved xerostomia in an elderly population and increased unstimulated and stimulated salivary flows rates.

• Authors: Gerardo Gómez-Moreno, Maribel Cabrera-Ayala, Antonio Aguilar-Salvatierra, Javier Guardia, María Piedad Ramírez-Fernández, Maximino González-Jaranay, José Luis Calvo-Guirado
• Journal: Gerodontology (Gerodontology) Vol. 31 Issue 4 Pg. 274-80 (Dec 2014) ISSN: 1741-2358 [Electronic] England
• PMID: 23294350 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2013 The Gerodontology Society and John Wiley & Sons A/S.

Chemical References

• Aerosols
• Malates
• Placebos
• Saliva, Artificial
• malic acid
• Fluorides
• Xylitol

Topics

• Administration, Oral
• Aerosols
• Aged
• Aged, 80 and over
• Double-Blind Method
• Female
• Fluorides (administration & dosage, therapeutic use)
• Humans
• Malates (administration & dosage, therapeutic use)
• Male
• Placebos
• Saliva (drug effects, metabolism)
• Saliva, Artificial (administration & dosage, therapeutic use)
• Secretory Rate (drug effects)
• Treatment Outcome
• Xerostomia (classification, drug therapy)
• Xylitol (administration & dosage, therapeutic use)