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IRCT20120101008585N10 IRCT 2021-11-10 Shiraz University of Medical Sciences The effect of platelet-rich plasma on oral lichen planus The effect of platelet-rich plasma on pain and size of oral lichen planus 2021-12-21 anticipated 15 Complete https://irct.ir/trial/59797 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each block with 4 allocations, consisting 2 allocation for intervention and 2 for control group will be considered. Six possible sequence of treatment allocation in each block will be listed and each one will be written on a card. 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 was performed by a methodologist. Allocation concealment will be done by the main researcher. On each 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 order of enrollment, Blinding description: The outcome assessor, patient and data analyzer will be blinded to the type of prescribed medication. 1-2 Oral lichen planus. Intervention 1: Intervention group: The prepared PRP will be injected around the lesion and intra lesion with anesthesia by insulin syringe. The injections will be performed twice (once every week) during first two weeks (days 0, 7, 14, 30, 60). Follow up sessions are weekly until the end of the second month (days 0, 7, 14, 30, 60). The VAS and thongpressom scale will assed the pain, size. The patient with two-sided OLP will be under routine treatment during the study. Both sides OLP lesions will be treated by triadent oral paste 0.1% (Raha Pharmaceutical company- Iran) twice in a day. The lesion on intervention side will receive PRP in addition to triadent. All participants will also be prescribed for 40 drops of Nystatin oral drop 100000U (Emad Darman Pars- Iran) twice in a day. Intervention 2: Control group: The patient with two-sided OLP will be under routine treatment during the study. Both sides OLP lesions will be treated by triadent oral paste 0.1% (Raha Pharmaceutical company- Iran) twice in a day. The lesion on control side will only receive triadent. All participants will also be prescribed for 40 drops of Nystatin oral drop 100000U (Emad Darman Pars- Iran) twice in a day.The VAS and thongpressom scale will assed the pain, size on days 0, 7, 14, 30, 60. Yes - There is a plan to make this available What will be shared: All collected data will be shared after 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 responsible person and request information How to obtain: The researchers in academic institutions can email responsible person and request information Comments:
public Shiraz University of Medical Sciences
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7186781559 +98 71 3631 9309 lavaeef@sums.ac.ir Iran 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 pregnant women The patients with history of malignancies or even dysplastic lesionsThe 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 prepared PRP will be injected around the lesion and intra lesion with anesthesia by insulin syringe. The injections will be performed twice (once every week) during first two weeks (days 0, 7, 14, 30, 60). Follow up sessions are weekly until the end of the second month (days 0, 7, 14, 30, 60). The VAS and thongpressom scale will assed the pain, size. The patient with two-sided OLP will be under routine treatment during the study. Both sides OLP lesions will be treated by triadent oral paste 0.1% (Raha Pharmaceutical company- Iran) twice in a day. The lesion on intervention side will receive PRP in addition to triadent. All participants will also be prescribed for 40 drops of Nystatin oral drop 100000U (Emad Darman Pars- Iran) twice in a day. Control group: The patient with two-sided OLP will be under routine treatment during the study. Both sides OLP lesions will be treated by triadent oral paste 0.1% (Raha Pharmaceutical company- Iran) twice in a day. The lesion on control side will only receive triadent. All participants will also be prescribed for 40 drops of Nystatin oral drop 100000U (Emad Darman Pars- Iran) twice in a day.The VAS and thongpressom scale will assed the pain, size on days 0, 7, 14, 30, 60. Pain. Timepoint: Days 0, 14, 30, 60. Method of measurement: Visual analogue scale. Size. Timepoint: Days 0, 14, 30, 60. Method of measurement: Scaled tongue blade(mm). Shiraz University of Medical Sciences Approved 2020-09-02 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)