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IRCT20250226064856N1 IRCT 2025-09-01 Ahvaz University of Medical Sciences Effect of Artificial Saliva on Controlling Dry Mouth in Patients with Sjogren's Syndrome Production and evaluation of the efficacy of a new Iranian artificial saliva in controlling the symptoms of dry mouth in patients with Sjogren's syndrome compared to placebo 2025-09-22 anticipated 50 Complete https://irct.ir/trial/84250 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: For randomization of the study, the block randomization method is used in such a way that 50 patients who meet the inclusion criteria are initially divided into five homogeneous blocks A to E of ten people each, based on age, gender, and duration of disease. Then, from the ten patients in each group, five people are randomly divided into two other subgroups of five people. These are known as Group 1 and Group 2, Blinding description: The bottles containing artificial saliva and placebo are prepared identically in terms of shape, color, and volume, and the number 1 or 2 will be written on the bottle. Only the person responsible for the production and packaging of the solutions will know the meaning of these numbers. When a patient enters the study, a code is assigned to them, in which a letter corresponding to the block they belong to and the number 1 or 2 corresponding to the subgroup within the block is assigned, and the next number 1 or 2 indicates the type of solution they are using, and the last number is from 1 to 5, representing the chronological order in which the individual entered the study. For example, the code E-1-2-5 for a patient means that this patient is the fifth patient who entered the study from Block E and Subgroup 1, and the type of solution assigned to them is Solution 2. This code will be written on each questionnaire and will also be communicated to the patient. The code will also be labeled on the bottle. 3 Sjogren's syndrome. 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: Control group: Participants in the control group received a placebo solution with the same appearance and dosage (10 ml per dose), used three times a day for two weeks. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after deidentification of individuals. When: The access period will begin 6 months after publication of the results To whom: Data may be requested by researchers affiliated with academic and scientific institutions, as well as individuals working in industry. Conditions: Data will be made available to requesters provided they present a reasonable justification that the information they seek cannot be obtained from the published article. Where to obtain: To request the documents, please contact via email at: dsshoriabii@yahoo.com How to obtain: تقاضای دسترسی به مستندات در جلسه ای که تمام مجریان طرح به صورت هفتگی تشکیل میدهند بررسی میشود و در صورت موافقت مستندات بسته به روشیی که قرار است برای درخواست کننده ارسال شود حداکثر تا سه ماه پس از درخواست به اشتراک گذاشته میشود Comments:
public Mohammad Shooryabi
Golestan Highway-Jundishapur University of Ahvaz
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3311 4155 shooryabi-m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mohammad Shooryabi
Golestan Highway-Jundishapur University of Ahvaz
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3311 4155 shooryabi-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 80 years Both 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. M35.0 Sicca syndrome [Sjogren] Treatment - Drugs Placebo 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. Control group: Participants in the control group received a placebo solution with the same appearance and dosage (10 ml per dose), used three times a day for two weeks. 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. Ahvaz University of Medical Sciences Approved 2025-01-10 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Golestan Street – Ahvaz Jundishapur University of Medical Sciences ahvaz Khouzestan Iran (Islamic Republic of)