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

Federal University of São Paulo

Status: Completed

Conditions: XEROSTOMIA; SICCA SYNDROME; PRIMARY SJOGREN SYNDROME; KERATOCONJUNCTIVITIS SICCA

Treatments: Device: Sham Lasertherapy; Device: Lasertherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02066896

LLLXS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with primary Sjogren Syndrome according criteria american european 2002.
• Salivary flux non stimulated < 0,1 ml/min.

Exclusion criteria

• hepatitis B and/or C
• radiotherapy in the glandular area (previous)
• other connective diseases
• thyroidopathy non compensated
• GVHD graft-versus-host disease
• HIV
• Sarcoidosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Sham Comparator: Sham Lasertherapy

Sham Comparator group

Description:

Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.

Treatment:

Device: Sham Lasertherapy

Active Comparator: Lasertherapy

Active Comparator group

Description:

Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.

Treatment:

Device: Lasertherapy