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IRCT20250715066509N1 IRCT 2025-08-18 Mashhad University of Medical Sciences Investigating the effect of dexamethasone and fluconazole mouthwash on oral lichen planus Investigating the therapeutic effect of formulated mouthwash containing dexamethasone and fluconazole on oral lichen planus 2025-09-23 anticipated 70 Complete https://irct.ir/trial/84935 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sealed envelope Sealed envelope method: The envelopes are prepared and printed by a member of the research team and random numbers are generated with the help of the website Randomaize.com. The printed sheets will be placed inside the envelope. The envelopes will be closed and their contents will not be visible from the outside. Then, initially, the purpose of the study is explained to the person who meets the conditions for entering the study and, if desired, they sign the informed consent form and take an envelope. Then, it is opened and based on the contents of the envelope, the person is entered into the intervention or control group. 3 Oral lichenplanus. Intervention 1: 5 ml of a mouthwash formulated with dexamethasone 0.1 mg/ml + fluconazole 2 mg/ml, 3 times a day for 3 weeks. Intervention 2: Control group: Mix a 0.5 mg tablet with 30 drops of nystatin 100,000 units and rinse 3 times a day for 3 weeks. Yes - There is a plan to make this available What will be shared: Some data including demographic properties, signs and symptoms When: 11 months after publication To whom: academic researchers Conditions: It is permitted to use the data in other studies with reference. Where to obtain: Dr Atessa Pakfetrat e-mail: pakfetrata@mums.ac.ir How to obtain: Sending email to authors. Comments:
public Dr. Ehsan Jannatabadi
Mashad,Vakilabad Blv, Dental school
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 jannatabadiE4031@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Atessa Pakfetrat
Mashhad Dental School, Azadi Square, Vakilabad Blvd
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 pakfetrata@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Adults over 18 and under 65 years of age People who are prescribed mouthwash due to the number or extent of pathological lesions, as approved by a specialist, and the severity of the lesions is equal to two or more according to the Thongprsom criteria. Those who have informed consent to participate in the study 18 years 65 years Both Severe problems due to systemic diseases (more than two according to the ASA classification). People who are unable to rinse their mouth with topical corticosteroids due to systemic or medication reasons. People who have severe dysplasia based on the pathology results People who, for whatever reason, do not wish to continue participating in the project. People who have allergies to the drug or a history of allergies to other components of the formulation. Topical and systemic use of corticosteroid medications in the last 3 weeks Pregnant and breastfeeding women Immunocompromised patients L43 Diseases of the skin and subcutaneous tissue, Papulosquamous disorders Treatment - Drugs Treatment - Drugs 5 ml of a mouthwash formulated with dexamethasone 0.1 mg/ml + fluconazole 2 mg/ml, 3 times a day for 3 weeks Control group: Mix a 0.5 mg tablet with 30 drops of nystatin 100,000 units and rinse 3 times a day for 3 weeks Severity of oral lichen planus lesions. Timepoint: At the beginning of the study /1 week/2 weeks/3 weeks. Method of measurement: Thongprosam. Pain and burning. Timepoint: At the beginning of the study /1 week/2 weeks/3 weeks. Method of measurement: Visual Analogue Scale (VAS). Treatment Satisfaction. Timepoint: End of the third week. Method of measurement: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Mashhad University of Medical Sciences Approved 2025-06-11 Mashhad University of Medical Sciences- Research Ethics Committee Mashhad Dental School, Azadi Square, Vakilabad Blvd mashhad Razavi Khorasan Iran (Islamic Republic of)