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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03612414
Other study ID # Prot.49 May 31st, 2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2016
Est. completion date December 15, 2017

Study information

Verified date July 2018
Source Università degli Studi dell'Insubria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Xerostomia is defined as the subjective complaint of dry mouth. Symptoms of dry mouth may range from mild oral discomfort to significant oral disease that can compromise patients' health, dietary intake and quality of life. Xerostomia is accompanied by numerous signs and symptoms mainly in the mucous membranes, lips, tongue, salivary glands and teeth.

This study was designed to verify efficacy and safety of a novel dietary supplement (Aqualief),designed with the aim of stabilizing the saliva flux and pH at a neutral level and to improve the acid buffering capacity of saliva.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Aqualief
Three tablets/day
Placebo
Three tablets/day

Locations

Country Name City State
Italy Università degli Studi dell'Insubria Varese

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of Aqualief on salivation Changes in saliva production is measured (ml) Change from baseline to 6 days of treatment
Secondary Safety of Aqualief Incidence of Treatment-Emergent Adverse Events Occurrence of Adverse Events over the 6 days of treatment
Secondary Effect of Aqualief on dry mouth symptoms Evaluate the effect of treatments dry mouth symptoms trough Dry Mouth Questionnaire (Thomson Questionnaire) Change from baseline to 6 days of treatment
Secondary Effect of Aqualief on the pH of saliva Changes of saliva pH is measured Change from baseline to 6 days of treatment
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