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

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ClinicalTrials.gov Identifier: NCT02066896
Recruitment Status : Completed
First Posted : February 20, 2014
Results First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
KERATOCONJUNCTIVITIS SICCA XEROSTOMIA SICCA SYNDROME PRIMARY SJOGREN SYNDROME Device: Lasertherapy Device: Sham Lasertherapy Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Level Laser Therapy For The Treatment Of Xerostomia In Primary Sjogren`s Syndrome
Study Start Date : May 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Sham Comparator: Sham Lasertherapy
Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Device: 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).
Active Comparator: Active Comparator: Lasertherapy
Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Device: 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)



Primary Outcome Measures :
  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:

    1. I sip liquids to aid in swallowing food
    2. My mouth feels dry when eating a meal
    3. I get up at night to drink
    4. My mouth feels dry
    5. I have difficulty in eating dry foods
    6. I suck sweets or cough lollies to relieve dry mouth
    7. I have difficulties swallowing certain foods
    8. The skin of my face feels dry
    9. My eyes feel dry
    10. My lips feel dry
    11. The inside of my nose feels dry __________________________________________________________

    Score:

    Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5)



Secondary Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066896


Locations
Brazil
Tania S A Fidelix
Sao Paulo, Brazil, 04602-000
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Virginia M Trevisani, PhD Federal University of Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: TANIA SALES DE ALENCAR FIDELIX, DR., Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02066896     History of Changes
Other Study ID Numbers: LLLXS
First Posted: February 20, 2014    Key Record Dates
Results First Posted: August 3, 2017
Last Update Posted: August 3, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo:
Sjogrens Syndrome
Syndrome, Sjogren's
Sjogren Syndrome
Sicca Syndrome
Syndrome, Sicca

Additional relevant MeSH terms:
Sjogren's Syndrome
Syndrome
Xerostomia
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases