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

April 24, 2017 updated by: TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04602-000
        • Tania S A Fidelix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Chair: Virginia M Trevisani, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LLLXS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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