Quality of Life and Sjögren Syndrome

Quality of Life Clinical Trial

Official title:

Quality of Life in a Portuguese Population With Primary Sjögren Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578900
• Other study ID #: QL2015
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: July 2018
• Source: Grupo de Investigação em Bioquímica e Biologia Oral
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyposalivation
• Quality of Life
• Sjogren's Syndrome
• Syndrome
• Xerostomia

Intervention

Drug:
• Xeros

• Citric Acid based Mouthwash

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Grupo de Investigação em Bioquímica e Biologia Oral	Dentaid, Portuguese Institute of Rheumatology, University of Lisbon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 minutes
Primary	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.	15 days
Secondary	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.	20 minutes