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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT02066896
First received: August 15, 2013
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
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 Intervention
KERATOCONJUNCTIVITIS SICCA XEROSTOMIA SICCA SYNDROME PRIMARY SJOGREN SYNDROME Device: Lasertherapy Device: Sham Lasertherapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo:

Primary Outcome Measures:
  • 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:
  • 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.


  • 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.



Enrollment: 66
Study Start Date: May 2014
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: August 15, 2013
Results First Received: February 22, 2017
Last Updated: April 24, 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

ClinicalTrials.gov processed this record on August 21, 2017