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

This study has been completed.
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Gerardo Gomez Moreno, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01652001
First received: July 20, 2012
Last updated: April 4, 2016
Last verified: April 2016
  Purpose

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 Intervention Phase
Xerostomia
Depression
Hypertension
Drug: Malic Acid
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Dry Mouth Questionnaire (DMQ) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

    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:
  • 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 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.



Enrollment: 185
Study Start Date: January 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Xerostomia
  • Drug consumption
  • Antidepressant and antihypertensive agents

Exclusion Criteria:

  • Systemic diseases
  • Head and neck radiotherapy
  • Intake of drugs with high xerostomizing capacity
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01652001

Locations
Spain
Dental School
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Instituto de Salud Carlos III
Investigators
Principal Investigator: Gerardo Gómez-Moreno, Professor Universidad de Granada
  More Information

Responsible Party: Gerardo Gomez Moreno, Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01652001     History of Changes
Other Study ID Numbers: Xerostomia-2012  PI10/00932 
Study First Received: July 20, 2012
Results First Received: December 3, 2014
Last Updated: April 4, 2016
Health Authority: Spain: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Universidad de Granada:
Xerostomia
Antidepressant agents
Antihypertensive agents

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 23, 2016