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

Study Overview
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Brief Summary
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This study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary Sjogren's Syndrome.

Detailed Description
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The Sjogren's Syndrome is a disease that affects around 0,5% of the population and is mainly characterized for inflammatory involvement of salivary and lacrimal glands. The xerostomia leads to low quality of life caused by dry sensations that can disturb the taste, the speaking, the swallow and chewing functions in the affected patients. The absent saliva can cause increase of dental caries and decays. Until now, there is no effective treatment that increases the amount of saliva and the patients have low improvements with cholinergic drugs such as pilocarpine and cevimeline. These drugs can cause unpleasant collateral effects.

Official Title
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Low Level Laser Therapy For The Treatment Of Xerostomia In Primary Sjogren's Syndrome

Conditions
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KERATOCONJUNCTIVITIS SICCA, XEROSTOMIA, SICCA SYNDROME, PRIMARY SJOGREN SYNDROME

Intervention / Treatment
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* Device: Lasertherapy
* Device: Sham Lasertherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary Sjogren Syndrome according criteria american european 2002. Salivary flux non stimulated < 0,1 ml/min. Exclusion Criteria: hepatitis B and/or C radiotherapy in the glandular area (previous) other connective diseases thyroidopathy non compensated GVHD graft-versus-host disease HIV Sarcoidosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Comparator: Sham Lasertherapy<br>Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks. | Device: Sham Lasertherapy<br>* 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).<br>|
| Active Comparator: Active Comparator: Lasertherapy<br>Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks. | Device: Lasertherapy<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Xerostomia Inventory | 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) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Biomarker Analysis. Beta 2 Microglobulin. | 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. | 6 weeks | 
| Salivary Flux Measurement | 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjogrens Syndrome, Syndrome, Sjogren's, Sjogren Syndrome, Sicca Syndrome, Syndrome, Sicca