Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01652001
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Gerardo Gomez Moreno, Universidad de Granada

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Xerostomia
Depression
Hypertension
Interventions Drug: Malic Acid
Other: Placebo
Enrollment 185
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Malic Acid 1% Control
Hide Arm/Group Description

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.

Malic Acid: Oral spray for application into the oral cavity

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).

Placebo: Oral spray for application into the oral cavity

Period Title: Overall Study
Started 100 85
Completed 91 79
Not Completed 9 6
Arm/Group Title Malic Acid 1% Control Total
Hide Arm/Group Description

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.

Malic Acid: Oral spray for application into the oral cavity

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).

Placebo: Oral spray for application into the oral cavity

Total of all reporting groups
Overall Number of Baseline Participants 100 85 185
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 85 participants 185 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
100
 100.0%
85
 100.0%
185
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 85 participants 185 participants
Female
68
  68.0%
55
  64.7%
123
  66.5%
Male
32
  32.0%
30
  35.3%
62
  33.5%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 100 participants 85 participants 185 participants
100 85 185
[1]
Measure Description: Participants were reruited from University of Granada who were attended at dental school
1.Primary Outcome
Title Dry Mouth Questionnaire (DMQ)
Hide Description

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

Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Malic Acid 1% Control
Hide Arm/Group Description:

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.

Malic Acid: Oral spray for application into the oral cavity

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).

Placebo: Oral spray for application into the oral cavity

Overall Number of Participants Analyzed 91 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.4  (0.6) 1.4  (0.5)
2.Secondary Outcome
Title Sialometries
Hide Description

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.

Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Malic Acid 1% Control
Hide Arm/Group Description:

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.

Malic Acid: Oral spray for application into the oral cavity

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).

Placebo: Oral spray for application into the oral cavity

Overall Number of Participants Analyzed 91 79
Mean (Standard Deviation)
Unit of Measure: mL/min
Unstimulated Salivary Flow rate 0.17  (0.07) 0.16  (0.09)
Stimulated Salivary Flow Rate 0.93  (0.27) 0.75  (0.35)
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Malic Acid 1% Control
Hide Arm/Group Description Patients treated with Malic Acid 1% Patients treated with a placebo
All-Cause Mortality
Malic Acid 1% Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Malic Acid 1% Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/85 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Malic Acid 1% Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/85 (0.00%) 
Some of the participants forgot the appointment because the time between phases were of two weeks
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gómez-Moreno
Organization: University of Granada
Phone: +34000000000
EMail: ggomez@ugr.es
Layout table for additonal information
Responsible Party: Gerardo Gomez Moreno, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01652001     History of Changes
Other Study ID Numbers: Xerostomia-2012
PI10/00932 ( Other Grant/Funding Number: Instituto de Salud Carlos III )
First Submitted: July 20, 2012
First Posted: July 27, 2012
Results First Submitted: December 3, 2014
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016