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Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01652001
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Gerardo Gomez Moreno, Universidad de Granada

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Xerostomia Depression Hypertension Drug: Malic Acid Other: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth
Drug Information available for: Malic acid

Arm Intervention/treatment
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
Oral spray for application into the oral cavity
Other Names:
  • XerosDentaid Spray
  • Flask labeled A

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: Placebo
Oral spray for application into the oral cavity
Other Name: Flask labeled B

Primary Outcome Measures :
  1. Dry Mouth Questionnaire (DMQ) [ Time Frame: 2 weeks ]

    Dry Mouth Questionnaire (DMQ) was used in order to obtain subjective information about the severity of xerostomia before and after treatment with malic acid/placebo.

    Every participant answered an initial questionnaire (DMQ 1) about the symptoms related to oral dryness, before receiving a spray (1% malic acid or placebo). 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. Increased DMQ scores indicate improvement of xerostomia. DMQ 1 was used to assess the initial severity of oral dryness and in particular its impact on oral function: problems when chewing, swallowing, speaking and general impact on daily life.

    DMQ 1 used a 0-to-4 rating scale where 0 = "very dry" and 4 = "not dry at all." After two weeks of treatment, DMQ 1 was repeated and it was included DMQ 2.

    At the end values of DMQ 1 and DMQ 2 were summed

Secondary Outcome Measures :
  1. Sialometries [ Time Frame: 2 weeks ]

    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 20 mL 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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Xerostomia
  • Drug consumption
  • Antidepressant and antihypertensive agents

Exclusion Criteria:

  • Systemic diseases
  • Head and neck radiotherapy
  • Intake of drugs with high xerostomizing capacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01652001

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Dental School
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Instituto de Salud Carlos III
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Principal Investigator: Gerardo Gómez-Moreno, Professor Universidad de Granada
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Responsible Party: Gerardo Gomez Moreno, Professor, Universidad de Granada Identifier: NCT01652001    
Other Study ID Numbers: Xerostomia-2012
PI10/00932 ( Other Grant/Funding Number: Instituto de Salud Carlos III )
First Posted: July 27, 2012    Key Record Dates
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gerardo Gomez Moreno, Universidad de Granada:
Antidepressant agents
Antihypertensive agents
Additional relevant MeSH terms:
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Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases