BACKGROUND: One of the most important antidepressants side effects is dry mouth. The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid on patients affected by dry mouth caused by antidepressants drug. MATERIALS AND METHODS: This research took the form of a double-blind, randomized clinical trial at Faculty of Dentistry of University of Granada (Spain). Seventy participants with antidepressant-induced dry mouth were divided into two groups: for the first "intervention group" (35 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second "control group" (35 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The dry mouth questionnaire (DMQ) was used to evaluate dry mouth symptoms before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after application, were measured. RESULTS:Dry mouth symptoms improved after 1% malic acid topical spray application (p < .05). After 2 weeks of 1% malic acid application, unstimulated and stimulated salivary flows rates increased significantly (p < .05). CONCLUSIONS: A sialogogue spray containing 1% malic acid improved dry mouth feeling of the patients suffering antidepressant-induced dry mouth and increased unstimulated and stimulated salivary flows rates.
RCT Entities:
BACKGROUND: One of the most important antidepressants side effects is dry mouth. The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid on patients affected by dry mouth caused by antidepressants drug. MATERIALS AND METHODS: This research took the form of a double-blind, randomized clinical trial at Faculty of Dentistry of University of Granada (Spain). Seventy participants with antidepressant-induced dry mouth were divided into two groups: for the first "intervention group" (35 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second "control group" (35 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The dry mouth questionnaire (DMQ) was used to evaluate dry mouth symptoms before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after application, were measured. RESULTS:Dry mouth symptoms improved after 1% malic acid topical spray application (p < .05). After 2 weeks of 1% malic acid application, unstimulated and stimulated salivary flows rates increased significantly (p < .05). CONCLUSIONS: A sialogogue spray containing 1% malic acid improved dry mouth feeling of the patients suffering antidepressant-induced dry mouth and increased unstimulated and stimulated salivary flows rates.
Authors: Bernardino Alcázar Navarrete; Pedro José Romero Palacios; Antonio Aguilar-Salvatierra; Javier Guardia; Gerardo Gómez-Moreno Journal: Clin Drug Investig Date: 2015-09 Impact factor: 2.859