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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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 19, 2014
Last verified: February 2014
  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: Laser 3R 790nm infrared Ga AIAs
Device: Laser 3R 790 nm infrared GaAIAs
Phase 2

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 fourth week ] [ 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 analysis by proteomic [ Time Frame: up to fourth week ] [ Designated as safety issue: No ]
    Saliva samples will be submitted to chromatography analysis and dual absorptiometry in order to analyse the protein profile

  • Salivary flux measurement [ Time Frame: up to fourth week ] [ 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: 34
Study Start Date: January 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sham Laser therapy
12 sessions of sham laser therapy (no active intervention)
Experimental: Laser therapy
12 sessions of laser therapy
Device: Laser 3R 790nm infrared Ga AIAs
The laser beam applied bilaterally in noncontact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ Equipment in a turn-off mode Laser therapy
Device: Laser 3R 790 nm infrared GaAIAs

The laser beam applied bilaterally in noncontact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland. Equipment in a turn-on mode

Laser therapy


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
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 tsafidelix@uol.com.br

Locations
Brazil
Tania S A Fidelix Recruiting
Sao Paulo, Brazil, 04602-000
Contact: Tania SA Fidelix, Dr    55 11 41255840    tsafidelix@uol.com.br   
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Virginia M Trevisani, PhD Federal University of Sao Paulo
  More Information

No publications provided

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 19, 2014
Health Authority: Brazil: Ethics Committee

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
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Xerostomia
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014