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

NCT02066896 | Completed Results

• 1 other identifier: LLLXS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

KERATOCONJUNCTIVITIS SICCA; XEROSTOMIA; SICCA SYNDROME; PRIMARY SJOGREN SYNDROME

Keywords

Sjogrens Syndrome; Syndrome, Sjogren's; Sjogren Syndrome; Sicca Syndrome; Syndrome, Sicca

Outcome Measures

Primary Outcomes (1)

• The Xerostomia Inventory

  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: 1. I sip liquids to aid in swallowing food 2. My mouth feels dry when eating a meal 3. I get up at night to drink 4. My mouth feels dry 5. I have difficulty in eating dry foods 6. I suck sweets or cough lollies to relieve dry mouth 7. I have difficulties swallowing certain foods 8. The skin of my face feels dry 9. My eyes feel dry 10. My lips feel dry 11. The inside of my nose feels dry \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Score: Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5)

  6 weeks

Secondary Outcomes (2)

• Salivary Biomarker Analysis. Beta 2 Microglobulin.

  6 weeks

• Salivary Flux Measurement

  6 weeks

Study Arms (2)

Sham Comparator: Sham Lasertherapy

SHAM COMPARATOR

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

Device: Sham Lasertherapy

Active Comparator: Lasertherapy

ACTIVE COMPARATOR

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

Device: Lasertherapy

Interventions

Lasertherapy 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)

Active Comparator: Lasertherapy

Sham Lasertherapy 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).

Sham Comparator: Sham Lasertherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Tania S A Fidelix

São Paulo, 04602-000, Brazil

Location

Related Publications (1)

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

  PMID: 29119483 DERIVED

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Xerostomia; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Tania Sales de Alencar Fidelix
• Organization: Federal University of Sao Paulo

fidelixtania@gmail.com

11991346992

Study Officials

• Virginia M Trevisani, PhD

  Federal University of São Paulo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: February 20, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 3, 2017
• Results First Posted: August 3, 2017

Record last verified: 2017-04

Locations

BR (1)