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Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome
This study is currently recruiting participants.
Verified October 2015 by TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo
Sponsor:
Federal University of São Paulo
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 1, 2016
Last verified: October 2015
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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: Lasertherapy Device: Sham Lasertherapy | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo:
Primary Outcome Measures:
- The xerostomia inventory [ Time Frame: up to sixth week (changes from baseline) ]The questionary has 11 questions with graduations 1-5 each question according to the severity of dryness.
Secondary Outcome Measures:
- Salivary biomarker analysis [ Time Frame: up to sixth week (changes from baseline) ]Saliva samples will be submitted to chemical analysis for sodium, chloro, Beta 2 microglobulin
- Salivary flux measurement [ Time Frame: up to sixth week (changes from baseline) ]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: | 72 |
| Study Start Date: | May 2014 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02066896
Please refer to this study by its ClinicalTrials.gov identifier: NCT02066896
Contacts
| Contact: Tania A Fidelix, investigator | 55 11 991346992 | fidelixtania@gmail.com |
Locations
| Brazil | |
| Tania S A Fidelix | Recruiting |
| Sao Paulo, Brazil, 04602-000 | |
| Contact: Tania SA Fidelix, Dr 55 11 41255840 fidelixtania@gmail.com | |
Sponsors and Collaborators
Federal University of São Paulo
Investigators
| Study Chair: | Virginia M Trevisani, PhD | Federal University of Sao Paulo |
More Information
| 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 1, 2016 |
| Individual Participant Data | |
| 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 Keratoconjunctivitis Xerostomia 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 |
ClinicalTrials.gov processed this record on June 26, 2017