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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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

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KERATOCONJUNCTIVITIS SICCA XEROSTOMIA SICCA SYNDROME PRIMARY SJOGREN SYNDROME

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sham Comparator: Sham Lasertherapy

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

Group Type SHAM_COMPARATOR

Sham Lasertherapy

Intervention Type DEVICE

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: Lasertherapy

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

Group Type ACTIVE_COMPARATOR

Lasertherapy

Intervention Type DEVICE

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)

Interventions

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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)

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No