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.