NCT01652001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

April 5, 2016

Completed
Last Updated

April 5, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

July 20, 2012

Results QC Date

December 3, 2014

Last Update Submit

April 4, 2016

Conditions

XerostomiaDepressionHypertension

Keywords

XerostomiaAntidepressant agentsAntihypertensive agents

Outcome Measures

Primary Outcomes (1)

  • Dry Mouth Questionnaire (DMQ)

    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

    2 weeks

Secondary Outcomes (1)

  • Sialometries

    2 weeks

Study Arms (2)

Malic Acid 1%

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Malic AcidDRUG

Oral spray for application into the oral cavity

Also known as: XerosDentaid Spray, Flask labeled A
Malic Acid 1%
PlaceboOTHER

Oral spray for application into the oral cavity

Also known as: Flask labeled B
Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Xerostomia
  • Drug consumption
  • Antidepressant and antihypertensive agents

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental School

Granada, Granada, 18071, Spain

Location

MeSH Terms

Conditions

XerostomiaDepressionHypertension

Interventions

malic acid

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesBehavioral SymptomsBehaviorVascular DiseasesCardiovascular Diseases

Limitations and Caveats

Some of the participants forgot the appointment because the time between phases were of two weeks

Results Point of Contact

Title
Dr. Gómez-Moreno
Organization
University of Granada
ggomez@ugr.es
+34000000000

Study Officials

  • Gerardo Gómez-Moreno, Professor

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 27, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 5, 2016

Results First Posted

April 5, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)