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

Participant Flow

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
Arm/Group Description	Sham lasertherapy in parotid, subma...	Low level lasertherapy in parotid, ...
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

Baseline Characteristics

Arm/Group Title		Sham Comparator: Sham Lasertherapy	Active Comparator: Lasertherapy	Total
Arm/Group Description		Sham lasertherapy in parotid, subma...	Low level lasertherapy in parotid, ...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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
Brazil		33	33	66

Outcome Measures

1.Primary Outcome


Title	The Xerostomia Inventory
Description	The	Description	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: I sip liquids to aid in swallowing food My mouth feels dry when eating a meal I get up at night to drink My mouth feels dry I have difficulty in eating dry foods I suck sweets or cough lollies to relieve dry mouth I have difficulties swallowing certain foods The skin of my face feels dry My eyes feel dry My lips feel dry The inside of my nose feels dry __________________________________________________________ Score: Never’ (1), Hardly ever’ (2), Occasionally’ (3), Fairly often’ (4), Very often’ (5)
Time Frame	6 weeks

Title

The Xerostomia Inventory

Time Frame

6 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat population. Last observation carried forward imputation method.


Arm/Group Title	Sham Comparator: Sham Lasertherapy	Active Comparator: Lasertherapy
Arm/Group Description:	Sham lasertherapy in parotid, subma...	Low level lasertherapy in parotid, ...
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)

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.
Description	The saliva in Sögre...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Sham Comparator: Sham Lasertherapy	Active Comparator: Lasertherapy
Arm/Group Description:	Sham lasertherapy in parotid, subma...	Low level lasertherapy in parotid, ...
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
Description	The salivary flux was me...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Sham Comparator: Sham Lasertherapy	Active Comparator: Lasertherapy
Arm/Group Description:	Sham lasertherapy in parotid, subma...	Low level lasertherapy in parotid, ...
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)

Adverse Events

Time Frame	10 weeks
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Sham Comparator: Sham Lasertherapy	Active Comparator: Lasertherapy
Arm/Group Description	Sham lasertherapy in parotid, subma...	Low level lasertherapy in parotid, ...
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%)
Serious Adverse Events 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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

EMail: fidelixtania@gmail.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fidelix T, Czapkowski A, Azjen S, Andriolo A, Neto PH, Trevisani V. Low-level laser therapy for xerostomia in primary Sjögren's syndrome: a randomized trial. Clin Rheumatol. 2018 Mar;37(3):729-736. doi: 10.1007/s10067-017-3898-9. Epub 2017 Nov 9.

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

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