Overview

Quality of Life and Sjögren Syndrome

Status:
Completed
Trial end date:
2016-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Grupo de Investigação em Bioquímica e Biologia Oral
Collaborators:
Dentaid
Dentaid SL
Portuguese Institute of Rheumatology
University of Lisbon
Treatments:
Citric Acid
Sodium Citrate
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.