CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 185 enrolled
Drug / intervention
Malic Acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01652001
NCT01652001Phase 3Completed

Effectiveness of Malic Acid 1% in Patients With Xerostomia Induced by Drugs. Determination of Salivary Mucins and Buffering Capacity

Universidad de Granada·interventional·Posted Jul 27, 2012·Updated Apr 5, 2016

In Brief

A Phase 3 clinical trial evaluating Malic Acid and Placebo for Xerostomia and 2 related conditions. Completed, enrolled 185 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2012
Enrollment StartJan 1, 2011
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.9 years ago

Interventions

Malic Aciddrug

Oral spray for application into the oral cavity

Placeboother

Oral spray for application into the oral cavity