Quality of Life and Sjögren Syndrome

Sponsor

Grupo de Investigação em Bioquímica e Biologia Oral (Other)

Overall Status

Completed

CT.gov ID

NCT03578900

Collaborator

University of Lisbon (Other), Portuguese Institute of Rheumatology (Other), Dentaid SL (Industry)

289

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Xerostomia Hyposalivation Quality of Life Sjogren's Syndrome	Drug: Xeros Drug: Citric Acid based Mouthwash	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

289 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Quality of Life in a Portuguese Population With Primary Sjögren Syndrome

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Dec 31, 2014

Actual Study Completion Date :

Dec 31, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Time of GSSS induced pH drop below 4.5 [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.
Overall and sub domains scores for each questionnaire [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.

Secondary Outcome Measures

Salivary stimulant induced salivary flow [20 minutes]
While using one of the two products saliva is collected, weighed and salivary flow is determined at fixed times during 20 minutes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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