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

Primary Purpose

KERATOCONJUNCTIVITIS SICCA, XEROSTOMIA, SICCA SYNDROME

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lasertherapy
Sham Lasertherapy
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for KERATOCONJUNCTIVITIS SICCA focused on measuring Sjogrens Syndrome, Syndrome, Sjogren's, Sjogren Syndrome, Sicca Syndrome, Syndrome, Sicca

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tania S A Fidelix

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham Comparator: Sham Lasertherapy

Active Comparator: Lasertherapy

Arm Description

Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.

Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.

Outcomes

Primary Outcome Measures

The Xerostomia Inventory
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: I sip liquids to aid in swallowing food My mouth feels dry when eating a meal I get up at night to drink My mouth feels dry I have difficulty in eating dry foods I suck sweets or cough lollies to relieve dry mouth I have difficulties swallowing certain foods The skin of my face feels dry My eyes feel dry My lips feel dry 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.
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
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.

Full Information

First Posted
August 15, 2013
Last Updated
April 24, 2017
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02066896
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
KERATOCONJUNCTIVITIS SICCA, XEROSTOMIA, SICCA SYNDROME, PRIMARY SJOGREN SYNDROME
Keywords
Sjogrens Syndrome, Syndrome, Sjogren's, Sjogren Syndrome, Sicca Syndrome, Syndrome, Sicca

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Comparator: Sham Lasertherapy
Arm Type
Sham Comparator
Arm Description
Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Arm Title
Active Comparator: Lasertherapy
Arm Type
Active Comparator
Arm Description
Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Intervention Type
Device
Intervention Name(s)
Lasertherapy
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Sham Lasertherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
The Xerostomia Inventory
Description
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: I sip liquids to aid in swallowing food My mouth feels dry when eating a meal I get up at night to drink My mouth feels dry I have difficulty in eating dry foods I suck sweets or cough lollies to relieve dry mouth I have difficulties swallowing certain foods The skin of my face feels dry My eyes feel dry My lips feel dry The inside of my nose feels dry __________________________________________________________ Score: Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Salivary Biomarker Analysis. Beta 2 Microglobulin.
Description
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.
Time Frame
6 weeks
Title
Salivary Flux Measurement
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia M Trevisani, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Tania S A Fidelix
City
Sao Paulo
ZIP/Postal Code
04602-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29119483
Citation
Fidelix T, Czapkowski A, Azjen S, Andriolo A, Neto PH, Trevisani V. Low-level laser therapy for xerostomia in primary Sjogren's syndrome: a randomized trial. Clin Rheumatol. 2018 Mar;37(3):729-736. doi: 10.1007/s10067-017-3898-9. Epub 2017 Nov 9.
Results Reference
derived

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

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