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

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ClinicalTrials.gov Identifier: NCT02066896
Recruitment Status : Completed
First Posted : February 20, 2014
Results First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE August 15, 2013
First Posted Date  ICMJE February 20, 2014
Results First Submitted Date  ICMJE February 22, 2017
Results First Posted Date  ICMJE August 3, 2017
Last Update Posted Date August 3, 2017
Study Start Date  ICMJE May 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
The Xerostomia Inventory [ Time Frame: 6 weeks ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
The Xerostomia Inventory [ Time Frame: up to fourth week ]
The questionary has 11 questions with graduations 1-5 each question according to the severity of dryness.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Salivary Biomarker Analysis. Beta 2 Microglobulin. [ Time Frame: 6 weeks ]
    The saliva in Sögren`s syndrome patients has a high level of beta 2 microglobulin reflecting progression of the disease and inflammatory process at glandular epithelium. The saliva samples were collected at the baseline and end point. Beta 2 microglobulin was determined by Elisa human kit (ABCAM ab 108885). The normal levels are 1,2 +/- 0,7 microg/ml, and for primary Sjögren`s syndrome 5,3 +/- 4,6 microg/ml. This measure was done in the samples of saliva before and after the lasertherapy for all patients.
  • Salivary Flux Measurement [ Time Frame: 6 weeks ]
    The salivary flux was measured at the same time, without previous meal or tooth brushing, drinking or eating, in a quiet room. Spilled saliva was collected in a graduated Falcon 15ml tube. The samples of saliva were frozen and stored at -20° C. Normal salivary stimulated flux is above 0,5 ml/min. Normal unstimulated salivary flux is above 0,2 ml/min.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
  • salivary analysis by proteomic [ Time Frame: up to fourth week ]
    Saliva samples will be submitted to chromatography analysis and dual absorptiometry in order to analyse the protein profile
  • Salivary Flux Measurement [ Time Frame: up to fourth week ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome
Official Title  ICMJE Low Level Laser Therapy For The Treatment Of Xerostomia In Primary Sjogren`s Syndrome
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • KERATOCONJUNCTIVITIS SICCA
  • XEROSTOMIA
  • SICCA SYNDROME
  • PRIMARY SJOGREN SYNDROME
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Sham Comparator: Sham Comparator: Sham Lasertherapy
    Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
    Intervention: Device: Sham Lasertherapy
  • Active Comparator: Active Comparator: Lasertherapy
    Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
    Intervention: Device: Lasertherapy
Publications * Fidelix T, Czapkowski A, Azjen S, Andriolo A, Neto PH, Trevisani V. Low-level laser therapy for xerostomia in primary Sjögren's syndrome: a randomized trial. Clin Rheumatol. 2018 Mar;37(3):729-736. doi: 10.1007/s10067-017-3898-9. Epub 2017 Nov 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2017)
66
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2014)
34
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02066896
Other Study ID Numbers  ICMJE LLLXS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Virginia M Trevisani, PhD Federal University of Sao Paulo
PRS Account Federal University of São Paulo
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP