Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome
PRIMARY SJOGREN SYNDROME
Device: Sham Lasertherapy
|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|
- The xerostomia inventory [ Time Frame: up to sixth week (changes from baseline) ] [ Designated as safety issue: No ]The questionary has 11 questions with graduations 1-5 each question according to the severity of dryness.
- Salivary biomarker analysis [ Time Frame: up to sixth week (changes from baseline) ] [ Designated as safety issue: No ]Saliva samples will be submitted to chemical analysis for sodium, chloro, Beta 2 microglobulin
- Salivary flux measurement [ Time Frame: up to sixth week (changes from baseline) ] [ 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.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Sham Comparator: Sham Comparator: Sham Lasertherapy
Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Device: 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).
Active Comparator: Active Comparator: Lasertherapy
Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02066896
|Contact: Tania A Fidelix, investigator||55 11 firstname.lastname@example.org|
|Tania S A Fidelix||Recruiting|
|Sao Paulo, Brazil, 04602-000|
|Contact: Tania SA Fidelix, Dr 55 11 41255840 email@example.com|
|Study Chair:||Virginia M Trevisani, PhD||Federal University of Sao Paulo|