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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 Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years (SD)
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
Number Analyzed 33 participants 33 participants 66 participants
Female
32
  97.0%
32
  97.0%
64
  97.0%
Male
1
   3.0%
1
   3.0%
2
   3.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 33 participants 33 participants 66 participants
33 33 66
1.Primary Outcome
Title The Xerostomia Inventory
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward imputation method.
Arm/Group Title Sham Comparator: Sham Lasertherapy Active Comparator: Lasertherapy
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 33 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
40.2  (8.3) 39.3  (8.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator: Sham Lasertherapy, Active Comparator: Lasertherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments ANOVA repeated measures
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments ANOVA repeated measures
2.Secondary Outcome
Title Salivary Biomarker Analysis. Beta 2 Microglobulin.
Hide Description

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.

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Comparator: Sham Lasertherapy Active Comparator: Lasertherapy
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 33 33
Median (Standard Deviation)
Unit of Measure: microg/ml
1.10  (3.63) 0.84  (4.93)
3.Secondary Outcome
Title Salivary Flux Measurement
Hide Description

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.

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Comparator: Sham Lasertherapy Active Comparator: Lasertherapy
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 33 33
Median (Standard Deviation)
Unit of Measure: ml/min
0.100  (0.164) 0.100  (0.114)
Time Frame 10 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham Comparator: Sham Lasertherapy Active Comparator: Lasertherapy
Hide Arm/Group Description

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)

All-Cause Mortality
Sham Comparator: Sham Lasertherapy Active Comparator: Lasertherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sham Comparator: Sham Lasertherapy Active Comparator: Lasertherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham Comparator: Sham Lasertherapy Active Comparator: Lasertherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Tania Sales de Alencar Fidelix
Organization: Federal University of Sao Paulo
Phone: 11991346992 ext 11
Responsible Party: TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02066896     History of Changes
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