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

Brief Title

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

Official Title

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

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.
    

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


Primary Outcome

The Xerostomia Inventory

Secondary Outcome

 Salivary Biomarker Analysis. Beta 2 Microglobulin.

Condition

KERATOCONJUNCTIVITIS SICCA

Intervention

Lasertherapy

Study Arms / Comparison Groups

 Sham Comparator: Sham Lasertherapy
Description:  Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

66

Start Date

May 2014

Completion Date

August 2016

Primary Completion Date

August 2016

Eligibility 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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Virginia M Trevisani, PhD, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT02066896

Organization ID

LLLXS


Responsible Party

Principal Investigator

Study Sponsor

Federal University of São Paulo


Study Sponsor

Virginia M Trevisani, PhD, Study Chair, Federal University of Sao Paulo


Verification Date

April 2017