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IRCT20201127049502N1 IRCT 2020-12-01 Shahid Beheshti University of Medical Sciences The effect of triamcinolone and Q10 coenzyme in the treatment of oral lichen planus Evaluating the effect of a combined mouthwash of triamcinolone acetonide 0.1% and Q10 coenzyme in the treatment of oral lichen planus 2020-12-20 anticipated 18 Complete https://irct.ir/trial/52640 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple method of randomization will be done. In this way, each patient is assigned a number (from 1 to 18), according to the referral time. Patients with odd numbers are then given mouthwash A and patients with even numbers are given mouthwash B. The type of each mouthwash A and B (which is triamcinolone mouthwash and which is triamcinolone and Q10 combination mouthwash) is unknown to the patient and researcher, and only the pharmacist is aware of that. At the end of the study, the type of mouthwashes will be asked for data decode and analysis, Blinding description: Mouthwashes are provided in the same color, smell, and appearance, in bottles of the same shape. In this study, the researcher and the patient will not know the type of drugs. (double-blind) Patient examination and evaluation of oral lesions are done by one person before and after the treatment. 3 oral lichen planus. Intervention 1: Intervention group: In this group, patients receive 0.1% triamcinolone mouthwash. mouthwash will be used four times a day in the amount of 15 ml each time (by the measure) and then patients shouldn't eat or drink anything for half an hour. The mouthwash should be gargled in the mouth for two minutes. Intervention 2: Intervention group: In this group, patients receive triamcinolone and coenzyme Q10 combined mouthwash. mouthwash will be used four times a day in the amount of 15 ml each time (by the measure) and then patients shouldn't eat or drink anything for half an hour. The mouthwash should be gargled in the mouth for two minutes. Yes - There is a plan to make this available What will be shared: All data is potentially publishable after Anonymizing patients' identities When: Data will be available 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Researchers working in academic and scientific institutions Where to obtain: Researchers working in academic and scientific institutions should send an email to the corresponding person and request the data How to obtain: Researchers working in academic and scientific institutions should send an email to the corresponding person and request the data Comments:
public Arezoo Rahimzamani
Department of Oral Medicine, Shahid Beheshti University of Medical Sciences, Daneshjou Blvd, Chamran Hwy
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2990 2311 zamani_arezoo@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mahin Bakhshi
Department of Oral Medicine, Shahid Beheshti University of Medical Sciences, Daneshjou Blvd, Chamran Hwy
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2990 2311 mahinbakhshi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with symptomatic oral lichen planus (erosive or atrophic form) who have a sense of burning or pain. The diagnosis is clinical (Wickham striae or papules) and in cases in which a definitive diagnosis of the lesion is difficult, a histopathological evaluation will be used. The patient should not have used topical corticosteroid treatments in the last two weeks or systemic corticosteroids in the last month. The patient should not have used analgesics and anesthetics. 18 years no limit Both Patients with lichenoid lesions caused by medication or dental materials Pregnant or lactating patients Patients with other lesions such as leukoplakia and systemic lupus in conjunction with lichen planus History of malignancy Non-cooperative patients and patients who do not use drugs L43 Lichen planus Treatment - Drugs Treatment - Drugs Intervention group: In this group, patients receive 0.1% triamcinolone mouthwash. mouthwash will be used four times a day in the amount of 15 ml each time (by the measure) and then patients shouldn't eat or drink anything for half an hour. The mouthwash should be gargled in the mouth for two minutes. Intervention group: In this group, patients receive triamcinolone and coenzyme Q10 combined mouthwash. mouthwash will be used four times a day in the amount of 15 ml each time (by the measure) and then patients shouldn't eat or drink anything for half an hour. The mouthwash should be gargled in the mouth for two minutes. Severity and size of the lesions based on REU index. Timepoint: baseline(day0), day15, day30. Method of measurement: Graded tongue blade. Amount of healing based on Efficacy Index. Timepoint: baseline(day0), day15, day30. Method of measurement: formula. Severity of burning sensation based on VAS Index. Timepoint: baseline(day0), day15, day30. Method of measurement: Scoring by the patient. Shahid Beheshti University of Medical Sciences Approved 2020-11-02 Ethics committee of Shahid Beheshti University of Medical Sciences Department of Oral Medicine, Shahid Beheshti University of Medical Sciences, Daneshjou Blvd, Chamran Hwy Tehran Tehran Iran (Islamic Republic of)