MedTrace Logo

Quality of Life and Sjögren Syndrome

NCT03578900 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2018-07-06

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Xeros

DRUG

Citric Acid based Mouthwash

Sponsors & Collaborators

  • University of Lisbon

    collaborator OTHER

  • Portuguese Institute of Rheumatology

    collaborator UNKNOWN

  • Dentaid SL

    collaborator INDUSTRY

  • Grupo de Investigação em Bioquímica e Biologia Oral

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2014-12-31
Completion
2016-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03578900 on ClinicalTrials.gov