Quality of Life and Sjögren Syndrome
Quality of Life in a Portuguese Population With Primary Sjögren Syndrome
1 other identifier
interventional
289
0 countries
N/A
Brief Summary
The aims of this study are: To compare salivary pH changes and stimulation efficacy of two different Gustatory Stimulants of Salivation (GSSS) in patients with Primary Sjögren Syndrome (PSS); To evaluate Primary Sjögren syndrome (PSS) impact and gustatory stimulants of salivary secretion (GSSS) on oral health related quality of life measured by a Portuguese version of Oral Health Impact Profile-14 (OHIP-14) and specific Xerostomia assessment questionnaires. The Products to be used are the Xeros® Dentaid system and a citric based mouthwash.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2013
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedFirst Submitted
Initial submission to the registry
May 18, 2018
CompletedFirst Posted
Study publicly available on registry
July 6, 2018
CompletedJuly 6, 2018
July 1, 2018
2 years
May 18, 2018
July 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time of GSSS induced pH drop below 4.5
On the day that the system is attributed the subject is asked to use one of the products and saliva is collected. pH variation is determined at fixed intervals during 20 minutes. Time in which salivary pH is below 4.5 is calculated as well as the number needed to treat and the absolute risk reduction.
20 minutes
Overall and sub domains scores for each questionnaire
Before and after usage of both products at home, the Summated Xerostomia Inventory-5 (range 0 to 15) to measure subjective feeling of dry mouth, Oral Health Impact Profile-14 (range 0 to 56) to measure quality of life perception related to the oral cavity. This last questionnaire is further divided into 7 subdomains: functional limitation, physical pain, psychological discomfort, physical disability, psychologic disability, social disability and handicap each ranging from 0 to 14. In both questionnaires the total score is the result of the sum of the individual scores in each question. In both questionnaires the higher the score the worse the outcome. The before and after scores obtained are then compared.
15 days
Secondary Outcomes (1)
Salivary stimulant induced salivary flow
20 minutes
Study Arms (5)
Xeros Group - Lozenge
EXPERIMENTALApplication 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.
Mouthwash group
ACTIVE COMPARATORApplication 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.
Xeros Group - Mouthwash
EXPERIMENTALApplication 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 Group - Gel
EXPERIMENTALApplication 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 Group - Toothpaste
EXPERIMENTALApplication 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.
Interventions
Eligibility Criteria
You may qualify if:
- unstimulated whole saliva secretion rate \< 0.1 ml/min
- 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
You may not qualify if:
- wearer of complete dental prosthesis
- those who were pregnant or lactating
- non-speakers of Portuguese.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grupo de Investigação em Bioquímica e Biologia Orallead
- University of Lisboncollaborator
- Portuguese Institute of Rheumatologycollaborator
- Dentaid SLcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2018
First Posted
July 6, 2018
Study Start
January 1, 2013
Primary Completion
December 31, 2014
Study Completion
December 31, 2016
Last Updated
July 6, 2018
Record last verified: 2018-07