Quality of Life and Sjögren Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03578900
• Date of registration: 18/05/2018
• Prospective Registration: No
• Primary sponsor: Grupo de Investigação em Bioquímica e Biologia Oral
• Public title: Quality of Life and Sjögren Syndrome
• Scientific title: Quality of Life in a Portuguese Population With Primary Sjögren Syndrome
• Date of first enrolment: January 1, 2013
• Target sample size: 289
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03578900
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Xerostomia

Hyposalivation

Quality of Life

Sjogren's Syndrome

Intervention(s)

Drug: Xeros

Drug: Citric Acid based Mouthwash

Primary Outcome(s)

Time of GSSS induced pH drop below 4.5 [Time Frame: 20 minutes]

Overall and sub domains scores for each questionnaire [Time Frame: 15 days]

Secondary Outcome(s)

Salivary stimulant induced salivary flow [Time Frame: 20 minutes]

Secondary ID(s)

QL2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dentaid SL

University of Lisbon

Portuguese Institute of Rheumatology