Back to resultsQuality of Life and Sjögren Syndrome
Primary Purpose
Xerostomia, Hyposalivation, Quality of Life
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Xeros
Citric Acid based Mouthwash
Sponsored by
About this trial
This is an interventional treatment trial for Xerostomia focused on measuring Xerostomia, Hyposalivation, Quality of Life, Sjogren's Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- wearer of complete dental prosthesis
- those who were pregnant or lactating
- non-speakers of Portuguese.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Xeros Group - Lozenge
Mouthwash group
Xeros Group - Mouthwash
Xeros Group - Gel
Xeros Group - Toothpaste
Arm Description
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Salivary stimulant induced salivary flow
While using one of the two products saliva is collected, weighed and salivary flow is determined at fixed times during 20 minutes.
Full Information
NCT ID
NCT03578900
First Posted
May 18, 2018
Last Updated
July 5, 2018
Sponsor
Grupo de Investigação em Bioquímica e Biologia Oral
Collaborators
University of Lisbon, Portuguese Institute of Rheumatology, Dentaid SL
1. Study Identification
Unique Protocol Identification Number
NCT03578900
Brief Title
Quality of Life and Sjögren Syndrome
Official Title
Quality of Life in a Portuguese Population With Primary Sjögren Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo de Investigação em Bioquímica e Biologia Oral
Collaborators
University of Lisbon, Portuguese Institute of Rheumatology, Dentaid SL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, Hyposalivation, Quality of Life, Sjogren's Syndrome
Keywords
Xerostomia, Hyposalivation, Quality of Life, Sjogren's Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
289 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xeros Group - Lozenge
Arm Type
Experimental
Arm Description
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.
Arm Title
Mouthwash group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Xeros Group - Mouthwash
Arm Type
Experimental
Arm Description
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.
Arm Title
Xeros Group - Gel
Arm Type
Experimental
Arm Description
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.
Arm Title
Xeros Group - Toothpaste
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Xeros
Intervention Type
Drug
Intervention Name(s)
Citric Acid based Mouthwash
Primary Outcome Measure Information:
Title
Time of GSSS induced pH drop below 4.5
Description
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.
Time Frame
20 minutes
Title
Overall and sub domains scores for each questionnaire
Description
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.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Salivary stimulant induced salivary flow
Description
While using one of the two products saliva is collected, weighed and salivary flow is determined at fixed times during 20 minutes.
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
wearer of complete dental prosthesis
those who were pregnant or lactating
non-speakers of Portuguese.
12. IPD Sharing Statement
Learn more about this trial
Quality of Life and Sjögren Syndrome
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