Sjogren's syndrome. Sicca syndrome [Sjogren]
Conditions
Interventions
Intervention 1: Intervention group: Participants in the intervention group received the synthesized artificial saliva solution (10 ml per dose), used three times a day for two weeks. Intervention 2: C
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: The patient's age must be between 18 and 80 years. The patient must have confirmed primary or secondary Sjögren's syndrome. The diagnosis of Sjögren's syndrome must be based on the criteria of the American College of Rheumatology. The patient must have had xerostomia (dry mouth) for at least three months. The patient must be willing to participate in the study. A written informed consent must be obtained from the patient. The diagnosis must be confirmed by a rheumatology specialist. A complete oral and dental examination must be possible at the first visit. The patient must be able to attend follow-up sessions and cooperate with the research team.
Exclusion criteria
Exclusion criteria: Family history of medical conditions with dry mouth or other oral disorders that could interfere (e.g., chronic oral infections, head and neck cancer with recent treatment that affected saliva). Presence of a disease or industrial/drug condition that would interfere with artificial saliva or its efficacy assessment (e.g., use of strong anti-salivary medications or salivary stimulants that are incompatible with the purpose of the study). Unwillingness or inability to pursue research or inability to provide informed consent. Participation in other clinical trials that could impact the studies. Known sensitivity or allergy to artificial saliva compounds or its ingredients. Pregnancy or breastfeeding (in some studies) or severe immunodeficiency. The presence of an active oral infection or other health conditions that may affect the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of dry mouth sensation will be measured based on the patient’s self-reported score using a Numerical Rating Scale (NRS) from 0 to 10, both before the intervention and after each two-week treatment period. Timepoint: Measurement of dry mouth severity at baseline (before intervention), at the end of week 2 of solution use, and at the end of week 5 of the study. Method of measurement: The severity of dry mouth was measured using the Numerical Rating Scale (NRS) from 0 to 10, as reported by the patient. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Shooryabi
Ahvaz University of Medical Sciences
Outcome results
None listed