Quality of Life and Sjögren Syndrome

Grupo de Investigação em Bioquímica e Biologia Oral289 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

289

Conditions

Xerostomia Hyposalivation Quality of Life Sjogren's Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 15 days

Secondary Outcomes

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.

Time frame: 20 minutes