Quality of Life in a Portuguese Population With Primary Sjögren Syndrome
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 289
- Primary Endpoint
- Overall and sub domains scores for each questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Xeros (Drug)
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.
Intervention: Xeros (Drug)
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.
Intervention: Xeros (Drug)
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.
Intervention: Xeros (Drug)
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.
Intervention: Citric Acid based Mouthwash (Drug)
Outcomes
Primary Outcomes
Overall and sub domains scores for each questionnaire
Time Frame: 15 days
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 of GSSS induced pH drop below 4.5
Time Frame: 20 minutes
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.
Secondary Outcomes
- Salivary stimulant induced salivary flow(20 minutes)