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IRCT20210112050013N2 IRCT 2021-06-30 Bojnourd University of Medical Sciences The assessment of the therapeutic effect of bee propolis on oral Lichen Planus treatment. The assessment of the therapeutic effect of bee propolis on oral Lichen Planus treatment. 2021-07-11 anticipated 40 Complete https://irct.ir/trial/56092 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random numbers table, Blinding description: Participant: Uninformed about being in the Intervention or Control Group. Researcher: Uninformed about the patients in Intervention or Control Group and prescribing drugs or placebo. Outcome Evaluator: Uninformed about the patients in the Intervention or Control Group and prescribing drugs or placebo. 3 Lichen planus. Intervention 1: Intervention group: Group A consumes Propolis in the form of mouthwash with a dose of 500 mg, according to the manufacturer's instructions once or twice a day after brushing; First rinse the mouth with water or serum (normal saline) and then immediately use mouthwash with a plastic cup on the glass. Each mouthwash should last at least 2-3 minutes. Avoid eating and drinking for 30 minutes after using the mouthwash. Intervention 2: Control group: Group B consumes placebo which is prescribed in the same form as the main drug and in the same way. Use mouthwash once or twice a day after brushing; First rinse the mouth with water or serum (normal saline) and then immediately use mouthwash with a plastic cup on the glass. Each mouthwash should last at least 2-3 minutes. Avoid eating and drinking for 30 minutes after using the mouthwash. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr. Javid Rasekhi
No. 12, Ferdowsi 19, South Ferdowsi St.
Bojnourd Iran (Islamic Republic of) 9418654360 +98 58 3272 9338 forooghsajedii12@gmail.com Bojnourd University of Medical Sciences scientific Dr. Javid Rasekhi
No. 12, Ferdowsi 19, South Ferdowsi St.
bojnourd Iran (Islamic Republic of) 9418654360 +98 58 3272 9338 forooghsajedii12@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Patients who are diagnosed with OLP by an oral specialist. People who have been willing to participate in the study and sign the informed consent form. no limit no limit Both Patients with any past or present immunological disease or disorder. Patients with any past or present allergic disease or disorder. Pregnant and lactating women. Susceptible Patients to bee sting and products. Patients who have used systemic or topical Glucocorticosteroids at least over the past one month. Patients with Lichen Planus extra-oral manifestations. Patients with any continuous medication history. Patients with oral Lichen Planus with evidence of dysplastic changes in the oral mucosa or a history of such changes in the past. Treatment - Drugs Placebo Intervention group: Group A consumes Propolis in the form of mouthwash with a dose of 500 mg, according to the manufacturer's instructions once or twice a day after brushing; First rinse the mouth with water or serum (normal saline) and then immediately use mouthwash with a plastic cup on the glass. Each mouthwash should last at least 2-3 minutes. Avoid eating and drinking for 30 minutes after using the mouthwash. Control group: Group B consumes placebo which is prescribed in the same form as the main drug and in the same way. Use mouthwash once or twice a day after brushing; First rinse the mouth with water or serum (normal saline) and then immediately use mouthwash with a plastic cup on the glass. Each mouthwash should last at least 2-3 minutes. Avoid eating and drinking for 30 minutes after using the mouthwash. Extent of Atrophic areas: The area of Atrophic areas measured by caliper in square millimeters.Extent of Ulcerative areas: The area of the wound area measured by the caliper. Area of Keratotic areas: Area of Keratotic areas measured by caliper. Intensity of pain and irritation: The scale of pain and oral mucosa irritation that the patient reports according to VAS. Timepoint: At the beginning of study and a month after the start of the study. Method of measurement: To measure the area of the affected areas, the largest lesion diameters are measured by a caliper and their product is considered as the area of the target area. If the patient has similar lesions in several areas, the area of all these areas will be added together and this amount will be reported. The scale of pain and irritation is measured by the Visual Analogue Scale. This method of measurement asks the patient to rate their pain and irritation from 0 (with no pain and irritation) to 10 (the most severe pain and irritation). Bojnourd University of Medical Sciences Approved 2021-03-14 Ethics Committee of North Khorasan University of Medical Sciences No. 12, Ferdowsi 19, South Ferdowsi St. bojnourd North Khorasan Iran (Islamic Republic of)