Xerostomia

Asialia

Hyposalivation

Mouth Dryness

Aqualief

Placebo

Fondazione IRCCS Istituto Nazionale dei Tumori

Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer

Evaluate the Effects of Aqualief® Mucoadhesive Tablets (a Food Supplement Based on Carnosine and Hibiscus) in Patients Who Developed Oral Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer

Change of saliva production, without mechanical stimulation.

Report from patients the facility to use and palatability of the product

Helsinn Healthcare SA

Latis S.r.l.

randomized, double blind, placebo controlled, cross over study

Oral and oropharyngeal swabs will be collected

Cystic Fibrosis

University of Minnesota

The Sinonasal Cavity as a Reservoir for Upper Airway Bacterial Development

The primary outcome measure will be the development and composition of bacterial communities throughout the respiratory tract during the first year of life. Community composition will be assessed using 16S rRNA sequencing, and differences between body sites will be calculated using standard ecological metrics.

Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.

Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.

Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).

Sham Comparator: Sham Lasertherapy

Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)

Active Comparator: Lasertherapy

Total

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

The Xerostomia Inventory (XI) is an 11-item questionnaire (Thomson et al, 1999). Scores to the 11 items are summated, providing a single score (5-55) representing the subjective severity of xerostomia. In 2012, da Mata published a validated version in portuguese and we used this version. The better score is the lowest. The significant variation is defined as 6 or more.
Bellow we describe all the 11 questions:
I sip liquids to aid in swallowing food
My mouth feels dry when eating a meal
I get up at night to drink
My mouth feels dry
I have difficulty in eating dry foods
I suck sweets or cough lollies to relieve dry mouth
I have difficulties swallowing certain foods
The skin of my face feels dry
My eyes feel dry
My lips feel dry
The inside of my nose feels dry __________________________________________________________
Score:
Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5)

The Xerostomia Inventory

The saliva in Sögren's syndrome patients has a high level of beta 2 microglobulin reflecting progression of the disease and inflammatory process at glandular epithelium.
The saliva samples were collected at the baseline and end point. Beta 2 microglobulin was determined by Elisa human kit (ABCAM ab 108885).
The normal levels are 1,2 +/- 0,7 microg/ml, and for primary Sjögren's syndrome 5,3 +/- 4,6 microg/ml.
This measure was done in the samples of saliva before and after the lasertherapy for all patients.

Salivary Biomarker Analysis. Beta 2 Microglobulin.

The salivary flux was measured at the same time, without previous meal or tooth brushing, drinking or eating, in a quiet room. Spilled saliva was collected in a graduated Falcon 15ml tube. The samples of saliva were frozen and stored at -20° C.
Normal salivary stimulated flux is above 0,5 ml/min. Normal unstimulated salivary flux is above 0,2 ml/min.

Salivary Flux Measurement

Overall Study

Tania Sales de Alencar Fidelix

KERATOCONJUNCTIVITIS SICCA

XEROSTOMIA

SICCA SYNDROME

PRIMARY SJOGREN SYNDROME

Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)

Lasertherapy

Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).

pilocarpine/karijes

Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer

The Sinonasal Cavity as a Reservoir for Upper Airway Bacterial Development

Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome

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