Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity
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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 |
- 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.
| Estimated Enrollment: | 185 |
| 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) |
| 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
N/A
Other Names:
|
|
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
N/A
Other Name: Flask labeled B
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Gerardo Góme-Moreno, Professor | +34645348383 | ggomez@ugr.es |
| Contact: Javier Guardia, Doctor | +34686973951 | odonto@correo.ugr.es |
| Spain | |
| Dental School | Recruiting |
| Granada, Spain, 18071 | |
| Contact: Gerardo Gómez-Moreno, Professor +34645348383 ggomez@ugr.es | |
| Contact: Javier Guardia, Doctor +34686973951 odonto@correo.ugr.es | |
| 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 |
More Information
No publications provided
| 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 |
| Last Updated: | July 24, 2012 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Universidad de Granada:
|
Xerostomia Antidepressant agents Antihypertensive agents |
Additional relevant MeSH terms:
|
Mouth Diseases Depression Depressive Disorder Hypertension Xerostomia Behavioral Symptoms Mood Disorders Mental Disorders |
Vascular Diseases Cardiovascular Diseases Salivary Gland Diseases Stomatognathic Diseases Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013