Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity
Recruitment status was Recruiting
The aim of our study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid on patients affected by xerostomia caused by drugs.
This research took the form of a double-blind, randomized clinical trial at Faculty of Dentistry of University of Granada (Spain). Participants with antidepressant-induced and antihypertensive-induce xerostomia were divided into two groups: for the first 'intervention group' a topical sialogogue spray (1% malic acid) was applied, while for the second 'control group', a placebo spray was applied; for both groups the sprays were applied on demand during two weeks. The Dry Mouth Questionnaire (DMQ) was used to evaluate xerostomia levels before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after application, were measured.
Drug: Malic Acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effectiveness of Malic Acid 1% in Patients With Xerostomia Induced by Drugs. Determination of Salivary Mucins and Buffering Capacity|
- Dry mouth questionnaire (DMQ) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
The DMQ is used in order to obtain subjective information about the severity of xerostomia before and after treatment with malic acid/placebo.
This test contains two questionnaire:
- An initial questionnaire (DMQ 1) about the symptoms related to oral dryness, before receiving a spray.
- After two weeks of applications, patients had to answer DMQ 1 again as well as an additional questionnaire (DMQ 2) about the efficacy of the sprays.
- Sialometries [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Unstimulated and stimulated salivary flow rates were assessed in all patients. The unstimulated salivary flow rate was obtained by the spit method every 30 seconds for 15 minutes. Saliva was collected in 20mL plastic containers, which were pre-weighted.
Stimulated whole saliva was obtained by chewing a 1 g piece of paraffin wax for six minutes. Saliva collected during the first minute was discarded, and then collected into the container every 30 seconds.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Malic Acid 1%
Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).
Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.
Drug: Malic Acid
Placebo Comparator: Control
Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).
Other Name: Flask labeled B
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652001
|Contact: Gerardo Góme-Moreno, Professorfirstname.lastname@example.org|
|Contact: Javier Guardia, Doctoremail@example.com|
|Granada, Spain, 18071|
|Contact: Gerardo Gómez-Moreno, Professor +34645348383 firstname.lastname@example.org|
|Contact: Javier Guardia, Doctor +34686973951 email@example.com|
|Principal Investigator: Gerardo Gómez-Moreno, Professor|
|Sub-Investigator: Javier Guardia, Doctor|
|Sub-Investigator: Antonio Aguilar-Salvatierra, Doctor|
|Principal Investigator:||Gerardo Gómez-Moreno, Professor||Universidad de Granada|