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
|Condition or disease||Intervention/treatment||Phase|
|KERATOCONJUNCTIVITIS SICCA XEROSTOMIA SICCA SYNDROME PRIMARY SJOGREN SYNDROME||Device: Lasertherapy Device: Sham Lasertherapy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Low Level Laser Therapy For The Treatment Of Xerostomia In Primary Sjogren`s Syndrome|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Sham Comparator: Sham Comparator: Sham Lasertherapy
Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
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).
Active Comparator: Active Comparator: Lasertherapy
Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
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)
- 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:
- I sip liquids to aid in swallowing food
- My mouth feels dry when eating a meal
- I get up at night to drink
- My mouth feels dry
- I have difficulty in eating dry foods
- I suck sweets or cough lollies to relieve dry mouth
- I have difficulties swallowing certain foods
- The skin of my face feels dry
- My eyes feel dry
- My lips feel dry
- The inside of my nose feels dry __________________________________________________________
Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066896
|Tania S A Fidelix|
|Sao Paulo, Brazil, 04602-000|
|Study Chair:||Virginia M Trevisani, PhD||Federal University of Sao Paulo|