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IRCT20221016056202N1 IRCT 2022-10-23 Shiraz University of Medical Sciences Comparing curcumin mediated photodynamic therapy and topical corticosteroid in tratment of oral OLP Comparing the therapeutic effects of curcumin mediated photodynamic therapy and topical corticosteroid in tratment of erosive OLP 2022-11-06 anticipated 14 Complete https://irct.ir/trial/66406 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each patient with bilateral erosive OLP included in the study will be considered as follows: one side of the lesion will be the case and the other side will be the control lesion. . The experimental and control side of each patient is randomly selected using randomized blocks. Each block was considered with 4 allocations, including 2 allocations for the intervention and 2 allocations for the control group. Six possible sequences of treatment allocation are listed in each block, each written on a card. Each time a block was selected and the treatment sequence was recorded until treatment allocation was completed for all 7 participants. Randomization will be done by the methodologist. Allocation concealment will be performed by the principal investigator. A sequence is written on each of the 14 cards and sealed. Pockets are placed in a box. An envelope will be assigned to each participant based on the order of registration, Blinding description: The main researcher, who is responsible for examining and evaluating the lesions before and after the intervention, is unaware of which of the bilateral lesions of the patients is the case or the control. Another researcher is responsible for conducting the therapeutic intervention. The patients do not know which lesions are in the case or control group. The statistician who performs the data analysis is unaware of the case group and control.As a result, the study will be triple blind. 3 oral lichen planus. Intervention 1: Intervention group: In each photodynamic therapy session Sinanomin 1%( Topical gel contains %1 curcumin as nanoliposome from Exir Nanosina company will applied for 10 minutes in the side that is randomly selected as the case. After that a light cure device will be applied for irradiation with a blue light emitting wavelength of 470 nm for 5 min. Intervention 2: Control group: The other side of each patient that is considered as the control side with receive a placebo irradiation for 5 minutes with no light. No - There is not a plan to make this available Justification or reason for not sharing IPD is I have decided to publish the article in domestic or foreign magazines. Complete information will be accessible in this way
public Hanieh Farahmand
Bagh Hoz Street, 6 Salah Building
shiraz Iran (Islamic Republic of) 71868-96754 +98 917 104 5288 h_farahmand@sums.ac.ir Shiraz University of Medical Sciences scientific Hanieh Farahmand
Baghe hoze
Shiraz Iran (Islamic Republic of) 71868-96754 +98 917 103 5288 h_farahmand@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of OLP by 2 oral medicine specialists Presence of bilateral errosive symptomatic lesions Patients willing to actively participate in the study Patients that are capable of performing the exact instructions of the treatment protocol. 18 years no limit Both Age < 18 years Pregnancy or lactation Uncontrolled systemic diseases (hepatopathies, coagulopathies,auto immune or haematological diseases) History of allergic reactions to the active ingredient (curcumin) used in the clinical trial Presence of histological signs of dysplasia in the biopsy specimen Evidence of lichenoid lesions due to specific causes (dental materials, use of drugs inducing lichenoid reactions such as hypertensive or diabetic medications, etc.) Smokers or heavy drinkers of alcohol. Diabetic patients Patients with photosensivity Lichenoid reaction L43 Lichen planus Treatment - Drugs Placebo Intervention group: In each photodynamic therapy session Sinanomin 1%( Topical gel contains %1 curcumin as nanoliposome from Exir Nanosina company will applied for 10 minutes in the side that is randomly selected as the case. After that a light cure device will be applied for irradiation with a blue light emitting wavelength of 470 nm for 5 min. Control group: The other side of each patient that is considered as the control side with receive a placebo irradiation for 5 minutes with no light. Pain. Timepoint: days 0 and 7 and 14 and 28 and 56. Method of measurement: visual analogue scale. Size of lesion. Timepoint: days 0 and 7 and 14 and 28 and 56. Method of measurement: Digital caliper. Clinical manifestations of inflammation. Timepoint: days 0 and 7 and 14 and 28 and 56. Method of measurement: Thongprasom sign scoring. Clinical Efficacy of treatment. Timepoint: days 0 and 7 and 14 and 28 and 56. Method of measurement: REU. Allergy to curcumin. Timepoint: days 1 and 3 and 5. Method of measurement: Observe the side effects of increased sensitivity. Research Vice President of Shiraz University of Medical Sciences Approved 2022-08-31 Research Ethics Committees of School of Dentistry- Shiraz University of Medical Sciences Zand Street, Namazi Square, Shiraz University of Medical Sciences shiraz Fars Iran (Islamic Republic of)