Trial record 12 of 101 for:
Sjögren's Syndrome
Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2014 by 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 19, 2014
Last verified: February 2014
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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: Laser 3R 790nm infrared Ga AIAs Device: Laser 3R 790 nm infrared GaAIAs |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 Federal University of São Paulo:
Primary Outcome Measures:
- The xerostomia inventory [ Time Frame: up to fourth week ] [ Designated as safety issue: No ]The questionary has 11 questions with graduations 1-5 each question according to the severity of dryness.
Secondary Outcome Measures:
- salivary analysis by proteomic [ Time Frame: up to fourth week ] [ Designated as safety issue: No ]Saliva samples will be submitted to chromatography analysis and dual absorptiometry in order to analyse the protein profile
- Salivary flux measurement [ Time Frame: up to fourth week ] [ Designated as safety issue: No ]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: | 34 |
| Study Start Date: | January 2014 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Sham Laser therapy
12 sessions of sham laser therapy (no active intervention)
|
|
|
Experimental: Laser therapy
12 sessions of laser therapy
|
Device: Laser 3R 790nm infrared Ga AIAs
The laser beam applied bilaterally in noncontact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ Equipment in a turn-off mode Laser therapy
Device: Laser 3R 790 nm infrared GaAIAs
The laser beam applied bilaterally in noncontact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland. Equipment in a turn-on mode Laser therapy |
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 |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 | tsafidelix@uol.com.br |
Locations
| Brazil | |
| Tania S A Fidelix | Recruiting |
| Sao Paulo, Brazil, 04602-000 | |
| Contact: Tania SA Fidelix, Dr 55 11 41255840 tsafidelix@uol.com.br | |
Sponsors and Collaborators
Federal University of São Paulo
Investigators
| Study Chair: | Virginia M Trevisani, PhD | Federal University of Sao Paulo |
More Information
No publications provided
| 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 19, 2014 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Federal University of São Paulo:
|
Sjogrens Syndrome Syndrome, Sjogren's Sjogren Syndrome Sicca Syndrome Syndrome, Sicca |
Additional relevant MeSH terms:
|
Dry Eye Syndromes Sjogren's Syndrome Syndrome Keratoconjunctivitis Keratoconjunctivitis Sicca Xerostomia Arthritis Arthritis, Rheumatoid Autoimmune Diseases Conjunctival Diseases Conjunctivitis Connective Tissue Diseases Corneal Diseases |
Disease Eye Diseases Immune System Diseases Joint Diseases Keratitis Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Pathologic Processes Rheumatic Diseases Salivary Gland Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015