Efficacy of a Dietary Supplement (Aqualief®) in Xerostomic Patients

Università degli Studi dell'Insubria

Status

Completed

Conditions

Saliva

Xerostomia Due to Hyposecretion of Salivary Gland

Quality of Life

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Aqualief

Study type

Interventional

Funder types

Other

Identifiers

NCT03612414

Prot.49 May 31st, 2016

Details and patient eligibility

About

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.

Full description

Sixty patients with xerostomia (grade 1-2 according to RTOG/EORTC) from different etiologies were recruited at the Clinica Odontoiatrica dell'Università degli studi dell'Insubria (Varese, Italy). Exclusion criteria were subjects under treatment using drugs to treat hyposalivation (e.g. pilocarpine) and xerostomia grade ≥ 3. Patients with severe hyposalivation were excluded (saliva flow rate at baseline <0.1 ml min-1) due to their inability to dissolve the tablet formulation.

Written informed consent was received from all patients before study initiation. The study was conducted in accordance with the principles laid out by the Declaration of Helsinki 1964 and its subsequent amendments and with the International Committee on Harmonization Guidelines for Good Clinical Practice and in compliance with local ethical and legal requirements. The study was approved by the ethics committee at the participating site.

The study was a prospective, randomized, double-blind, placebo-controlled trial undertaken at the Clinica Odontoiatrica dell'Università degli Studi dell'Insubria (Varese, Italy). Eligible patients who had developed xerostomia RTOG/EORTC grade 1-2 were randomized in a 1:1 ratio, with one group receiving three Aqualief tablets (after meals: breakfast, lunch, dinner) daily for 6 days. The second group received a placebo tablet given with the same regimen. The primary objective of the study was to assess the safety and efficacy of Aqualief in stabilizing the saliva pH at a neutral level compared with placebo. The secondary objective was to determine whether Aqualief induced an increase of unstimulated or stimulated saliva and in ameliorating the symptoms related to oral dryness.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects of both sex
Age ≥ a 18 years
Able to understand and sign the Informed Consent, and fill in the patient's diary
Subjects suffering from Xerosotmia Grade 1-2 (according to RTOG/EORTC scale)
Sjögren Sindrome
Lambert-Eaton Sindrome
Diabetes mellitus and low metabolic control
Anxiety
Alcool abuse
Salivary glands trauma
Radio and Chemotherapy for head & neck cancer
Methamphetamine, cannabis, heroin abuse
Xerostomia caused by (single and concomitant, i.e. Anti-depressive and anxyolitic drugs; Antihistaminic drugs; Decongestive drugs; Antihypertensive drugs; Muscle relaxants; Urinary incontinence drugs; Drugs for Parkinson treatment)
Subjects affected by paradental pathology diagnosed according to AAOP criteria, PSR 2-3

Exclusion criteria

Contraindication and/or Hypersensitivity to product's components, and in particular carnosine and Hibiscus
Subjects that are under treatment with products or drugs ( ie pilocarpin) for hypofunctionality of salivary glands
Subjects with total ablation of salivary glands caused by chemo or radiotherapy
Use of experimental drugs during 30 days before the enrolment or during the study
Conditions that can interfere with the study
Xerostomia grade 3 or higher