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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Comparator: Sham Lasertherapy | Sham Comparator | Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks. |
|
| Active Comparator: Lasertherapy | Active Comparator | Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasertherapy | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Score: Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia M Trevisani, PhD | Federal University of São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tania S A Fidelix | São Paulo | 04602-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29119483 | Derived | 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. |
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Comparator: Sham Lasertherapy | 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). |
| FG001 | Active Comparator: Lasertherapy | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Comparator: Sham Lasertherapy | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
Score: Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5) | Intent to treat population. Last observation carried forward imputation method. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Comparator: Sham Lasertherapy | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tania Sales de Alencar Fidelix | Federal University of Sao Paulo | 11991346992 | 11 | fidelixtania@gmail.com |
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| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| D014987 | Xerostomia |
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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|
| Sham Lasertherapy | Device | 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). |
|
| 6 weeks |
| 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. | 6 weeks |
| Active Comparator: Lasertherapy |
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) |
| BG002 | Total | Total of all reporting groups |
| years (SD) |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Sham Comparator: Sham Lasertherapy | 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). |
| OG001 | Active Comparator: Lasertherapy | 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) |
|
|
|
| Secondary | 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. | Posted | Median | Standard Deviation | microg/ml | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Median | Standard Deviation | ml/min | 6 weeks |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Active Comparator: Lasertherapy | 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) | 0 | 33 | 0 | 33 | 0 | 33 |
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| D007634 |
| Keratitis |
| D003316 | Corneal Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |