Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
289 participants
INTERVENTIONAL
2013-01-01
2016-12-31
Brief Summary
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The Products to be used are the Xeros® Dentaid system and a citric based mouthwash.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Xeros Group - Lozenge
Application of Xeros system for 15 days. Lozenge (Malic acid 28.56 mg, Xylitol 421,98 mg, Sodium fluoride 0.55 mg) or Spray (Malic acid 1%, Xylitol 10%, Sodium fluoride 0.05%) 4 times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires.
Effects of lozenge on hyposalivation and pH variation determined by saliva collection with pre-weighed falcon and a ph electrode at predetermined times during a 20 minute period.
Xeros
Mouthwash group
Application of citric acid based Mouthwash (0,33% citric acid) for 15 days four times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires.
Effects of mouthwash on hyposalivation and pH variation determined by saliva collection with pre-weighed falcon and a pH electrode at predetermined times during a 20 minute period.
Citric Acid based Mouthwash
Xeros Group - Mouthwash
Application of Xeros system for 15 days. Mouthwash (Betaine 1.33%, Xylitol 3.30%, Sodium fluoride 0.05%, Allantoin 0.10%) 2 times a day.
Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires.
Xeros
Xeros Group - Gel
Application of Xeros system for 15 days. Gel (Betaine 1%, Aloe Vera 0.05%, Xylitol 10%, Sodium Fluoride 0.0033%) before bed.
Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires.
Xeros
Xeros Group - Toothpaste
Application of Xeros system for 15 days. Toothpaste (Betaine 4%, Xylitol 10%, Sodium Fluoride 0.33%, Allantoin 0.10%) 3 times a day.
Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires.
Xeros
Interventions
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Xeros
Citric Acid based Mouthwash
Eligibility Criteria
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Inclusion Criteria
* stimulated whole saliva secretion rate \> 0.2 ml/min
* above 18 years of age
* Primary Sjogren Syndrome diagnostic according to the European-American Consensus Group
Exclusion Criteria
* those who were pregnant or lactating
* non-speakers of Portuguese.
18 Years
ALL
No
Sponsors
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University of Lisbon
OTHER
Portuguese Institute of Rheumatology
UNKNOWN
Dentaid SL
INDUSTRY
Grupo de Investigação em Bioquímica e Biologia Oral
OTHER
Responsible Party
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Other Identifiers
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QL2015
Identifier Type: -
Identifier Source: org_study_id
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