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IRCT20120101008585N9 IRCT 2021-10-29 Shiraz University of Medical Sciences Evaluation of the effect of Shilajit on oral lichen planus lesions The effect of Mumijo (Shilajit) mouthwash on pain and healing of oral lichen planus 2021-12-22 anticipated 30 Complete https://irct.ir/trial/59510 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each block with 4 allocations, consisting of 2 allocations for intervention and 2 for the control group will be considered. Six possible sequences of treatment allocation in each block will be listed and each one will be written on a card. For each time, a block will be selected and the sequence of treatment will be registered until the treatment allocations become completed for all 30 participants (8 blocks). The randomization is performed by a methodologist. Allocation concealment is done by the main researcher. On every 30 cards, a sequence will be written and sealed. Pockets will be put in a box. A pocket will be allocated for each participant based on the order of enrollment, Blinding description: The outcome assessor will be blinded to the type of prescribed medication. 1-2 Lichen planus. Intervention 1: Intervention group: the patient in the intervention group will be prescribed Triamcinolone mouthwash (Raha Daru- Isfahan) 3 times a day for a month in order not to be derivate from routine treatment. This mouthwash will be prepared by mixing 10 vials of an amp. Triamcinolone 40 mg/ml in 200 cc boiled cooled water. For each time, 10 ml of this mouthwash will be gargled. They will be prescribed Shilajit mouthwash either. The Shilajit mouthwash will be used topically three times a day for a month (10 ml) it will be gargled for 4 minutes and the participants should not eat or drink for 30 minutes after using the mouthwash. After each meal, it will be prescribed. Similar to the control group, nystatin mouthwash will be prescribed for them for the candida infection control. Intervention 2: Control group: in the control group, patients will be prescribed Triamcinolone mouthwash (Raha Daru- Isfahan) 3 times a day for a month. This mouthwash will be prepared by mixing 10 vials of an amp. Triamcinolone 40 mg/ml in 200 cc boiled cooled water. For each time, 10 ml of this mouthwash will be gargled. All the patients same as the intervention group will be prescribed to use nystatin mouthwash for candida infection control. Yes - There is a plan to make this available What will be shared: All collected data will be shared after the deidentification of participants. When: 6 months after publication data will become available. To whom: The researchers in academic institutions Conditions: The researchers in academic institutions. Where to obtain: The researchers in academic institutions can email the responsible persons and request information. How to obtain: The researchers in academic institutions can email the responsible persons and request information. Comments:
public Fatemeh Lavaee
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7186781559 +98 71 3631 9309 lavaeef@sums.ac.ir Shiraz University of Medical Sciences scientific Fatemeh Lavaee
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7186781559 +98 71 3631 9309 lavaeef@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) The patients with atrophic or erosive oral lichen planus The patients with histopathology and clinically conformed lichen planus The patients who will be referred to Oral and Maxillofacial Disease Department of Shiraz Dental School 18 years no limit Both The patients with history of other inflammatory diseases The patients with history of malignancies or even dysplastic lesions The patients who have received treatment for oral lichen planus lesions since a previous month pregnant women L43 Lichen planus Treatment - Drugs Treatment - Drugs Intervention group: the patient in the intervention group will be prescribed Triamcinolone mouthwash (Raha Daru- Isfahan) 3 times a day for a month in order not to be derivate from routine treatment. This mouthwash will be prepared by mixing 10 vials of an amp. Triamcinolone 40 mg/ml in 200 cc boiled cooled water. For each time, 10 ml of this mouthwash will be gargled. They will be prescribed Shilajit mouthwash either. The Shilajit mouthwash will be used topically three times a day for a month (10 ml) it will be gargled for 4 minutes and the participants should not eat or drink for 30 minutes after using the mouthwash. After each meal, it will be prescribed. Similar to the control group, nystatin mouthwash will be prescribed for them for the candida infection control. Control group: in the control group, patients will be prescribed Triamcinolone mouthwash (Raha Daru- Isfahan) 3 times a day for a month. This mouthwash will be prepared by mixing 10 vials of an amp. Triamcinolone 40 mg/ml in 200 cc boiled cooled water. For each time, 10 ml of this mouthwash will be gargled. All the patients same as the intervention group will be prescribed to use nystatin mouthwash for candida infection control. Pain. Timepoint: Week: 1, 2 , 4, and 8. Method of measurement: Visual analogue scale. Lesion size. Timepoint: Week: 1, 2 , 4, and 8. Method of measurement: Scaled tongue blade (mm). Clinical presentation or inflammation. Timepoint: Week: 1, 2 , 4, and 8. Method of measurement: Thongprasom sign scoring. Shiraz University of Medical Sciences Approved 2020-07-26 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Namazi square, Zand street, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)