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

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ClinicalTrials.gov Identifier: NCT02066896

Recruitment Status : Completed

First Posted : February 20, 2014

Results First Posted : August 3, 2017

Last Update Posted : August 3, 2017

Sponsor:

Information provided by (Responsible Party):

TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo

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.

Condition or disease	Intervention/treatment	Phase
KERATOCONJUNCTIVITIS SICCA XEROSTOMIA SICCA SYNDROME PRIMARY SJOGREN SYNDROME	Device: Lasertherapy Device: Sham Lasertherapy	Not Applicable

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	66 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Low Level Laser Therapy For The Treatment Of Xerostomia In Primary Sjogren`s Syndrome
Study Start Date :	May 2014
Actual Primary Completion Date :	August 2016
Actual Study Completion Date :	August 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Sjögren syndrome

MedlinePlus related topics: Dry Mouth Sjogren's Syndrome

U.S. FDA Resources

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

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)

Secondary Outcome Measures :

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.
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066896

Locations


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

Sponsors and Collaborators

Federal University of São Paulo

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fidelix T, Czapkowski A, Azjen S, Andriolo A, Neto PH, Trevisani V. Low-level laser therapy for xerostomia in primary Sjögren's syndrome: a randomized trial. Clin Rheumatol. 2018 Mar;37(3):729-736. doi: 10.1007/s10067-017-3898-9. Epub 2017 Nov 9.


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
First Posted:	February 20, 2014 Key Record Dates
Results First Posted:	August 3, 2017
Last Update Posted:	August 3, 2017
Last Verified:	April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo:


Sjogrens Syndrome Syndrome, Sjogren's Sjogren Syndrome Sicca Syndrome Syndrome, Sicca

Additional relevant MeSH terms:


Syndrome Sjogren's Syndrome Dry Eye Syndromes Xerostomia Keratoconjunctivitis Keratoconjunctivitis Sicca 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

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