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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Federal University of São Paulo
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: February 1, 2016
Last verified: October 2015
  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 Phase
KERATOCONJUNCTIVITIS SICCA
XEROSTOMIA
SICCA SYNDROME
PRIMARY SJOGREN SYNDROME
Device: Lasertherapy
Device: Sham Lasertherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Federal University of São Paulo:

Primary Outcome Measures:
  • The xerostomia inventory [ Time Frame: up to sixth week (changes from baseline) ] [ Designated as safety issue: No ]
    The questionary has 11 questions with graduations 1-5 each question according to the severity of dryness.


Secondary Outcome Measures:
  • Salivary biomarker analysis [ Time Frame: up to sixth week (changes from baseline) ] [ Designated as safety issue: No ]
    Saliva samples will be submitted to chemical analysis for sodium, chloro, Beta 2 microglobulin

  • Salivary flux measurement [ Time Frame: up to sixth week (changes from baseline) ] [ Designated as safety issue: No ]
    The salivary flux will be measured at the same time, without previous meal or tooth brushing, drinking or eating, in a quiet room, spilled saliva in a collector tube graduated in mm.


Estimated Enrollment: 72
Study Start Date: May 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: June 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)
Genders Eligible for Study:   Both
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

Contacts
Contact: Tania A Fidelix, investigator 55 11 991346992 fidelixtania@gmail.com

Locations
Brazil
Tania S A Fidelix Recruiting
Sao Paulo, Brazil, 04602-000
Contact: Tania SA Fidelix, Dr    55 11 41255840    fidelixtania@gmail.com   
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
Last Updated: February 1, 2016
Health Authority: Brazil: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by 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 September 26, 2016