Quality of Life and Sjögren Syndrome

Quality of Life in a Portuguese Population With Primary Sjögren Syndrome

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 Overview

• Status: Completed
• Conditions: Quality of Life; Sjogren's Syndrome; Xerostomia; Hyposalivation
• Intervention / Treatment: Drug: Xeros; Drug: Citric Acid based Mouthwash

• Study Type: Interventional
• Enrollment (Actual): 289
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Xeros
Active Comparator: 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.	Drug: Citric Acid based Mouthwash
Experimental: 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.	Drug: Xeros
Experimental: 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.	Drug: Xeros
Experimental: 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.	Drug: Xeros

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	20 minutes

Collaborators and Investigators

• Sponsor: Grupo de Investigação em Bioquímica e Biologia Oral
• Collaborators: University of Lisbon; Dentaid SL; Portuguese Institute of Rheumatology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 31, 2014
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: July 5, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Quality of Life; Xerostomia; Sjogren's Syndrome; Hyposalivation
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome; Xerostomia; Molecular Mechanisms of Pharmacological Action; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Citric Acid; Sodium Citrate
• Other Study ID Numbers: QL2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No