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
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
KERATOCONJUNCTIVITIS SICCA XEROSTOMIA SICCA SYNDROME PRIMARY SJOGREN SYNDROME |
Interventions |
Device: Lasertherapy Device: Sham Lasertherapy |
Enrollment | 66 |
Recruitment Details | The study sample consisted of 66 patients who were selected from 84 patients referred from ophthalmology and rheumatology division of university hospital. The patients met primary Sjögren's criteria (2002). |
Pre-assignment Details | The exclusion criteria were: sarcoidosis, uncontrolled thyroidopathy, HIV and HCV infections and head or neck irradiation history. A computer-generated randomization list was used to allocate patients ramdomly into two groups: active laser therapy and sham laser therapy. Concealed randomization was performed with opaque sealed envelopes. |
Arm/Group Title | Sham Comparator: Sham Lasertherapy | Active Comparator: Lasertherapy |
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Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks. 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). |
Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks. 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) |
Period Title: Overall Study | ||
Started | 33 | 33 |
Completed | 33 | 33 |
Not Completed | 0 | 0 |
Arm/Group Title | Sham Comparator: Sham Lasertherapy | Active Comparator: Lasertherapy | Total | |
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Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks. 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). |
Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks. 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) |
Total of all reporting groups | |
Overall Number of Baseline Participants | 33 | 33 | 66 | |
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[Not Specified]
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Age, Continuous
Median (Standard Deviation) Unit of measure: Years (SD) |
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Number Analyzed | 33 participants | 33 participants | 66 participants | |
58 (11.1) | 54 (11.3) | 57 (11.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 33 participants | 33 participants | 66 participants | |
Female |
32 97.0%
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32 97.0%
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64 97.0%
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Male |
1 3.0%
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1 3.0%
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2 3.0%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | 0 participants | 0 participants | |
0 | ||||
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Brazil | Number Analyzed | 33 participants | 33 participants | 66 participants |
33 | 33 | 66 |
Name/Title: | Tania Sales de Alencar Fidelix |
Organization: | Federal University of Sao Paulo |
Phone: | 11991346992 ext 11 |
EMail: | fidelixtania@gmail.com |
Responsible Party: | TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT02066896 |
Other Study ID Numbers: |
LLLXS |
First Submitted: | August 15, 2013 |
First Posted: | February 20, 2014 |
Results First Submitted: | February 22, 2017 |
Results First Posted: | August 3, 2017 |
Last Update Posted: | August 3, 2017 |