drugset / Trial / NCT03578900
Quality of Life and Sjögren Syndrome
Phase 4
Completed
289 enrolled
Grupo de Investigação em Bioquímica e Biologia Oral
Dentaid SL · collabPortuguese Institute of Rheumatology · collabUniversity of Lisbon · collab
RandomizedCrossoverDouble-blindTreatment
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.
Timeline
- Start
- 2013-01-01
- Primary completion
- 2014-12-31
- Completion
- 2016-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Citric Acid based Mouthwash | Unknown | 0.33 % | — |
| Subject | Xeros | Unknown | — | — |