NCT02066896

Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome

Low Level Laser Therapy For The Treatment Of Xerostomia In Primary Sjogren's Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• KERATOCONJUNCTIVITIS SICCA
• XEROSTOMIA
• SICCA SYNDROME
• PRIMARY SJOGREN SYNDROME

Interventions

Type	Name	Description
DEVICE	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)
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).

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-02-20
• Last updated: 2017-08-03
• Results posted: 2017-08-03

Locations

1 site across 1 country: Brazil