Phase 3 N=185 Randomized Double-blind Treatment

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

Xerostomia · Depression · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01652001 ↗

Enrolled (actual)

185

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcome: Primary: Dry Mouth Questionnaire (DMQ) — 3.4; 1.4 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Malic Acid (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Universidad de Granada
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Dry Mouth Questionnaire (DMQ)	3.4; 1.4	—
SECONDARY Sialometries	0.17; 0.16; 0.93; 0.75	—

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT01652001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.