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Completed

NCT Number: NCT02066896

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lasertherapy

Device

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)

Sham Lasertherapy

Device

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).

Primary outcomes

  1. The Xerostomia Inventory

    Time frame: 6 weeks

    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)

Secondary outcomes

  1. Salivary Biomarker Analysis. Beta 2 Microglobulin.

    Time frame: 6 weeks

    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.

  2. Salivary Flux Measurement

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2014
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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