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IRCT20150609022628N1 IRCT 2025-07-19 Esfahan University of Medical Sciences The effect of photodynamic therapy on the Treatment of ulcerative-erosive oral lichen planus The effect of adding photodynamic therapy to corticosteroid mouthwash on the Treatment of ulcerative-erosive oral lichen planus 2025-05-13 anticipated 36 Complete https://irct.ir/trial/83488 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will be conducted on 36 patients with oral ulcerative-erosive lichen planus. Using the Random-Allocation version 1.0.0 software, patients will be randomly assigned to two groups in a block-wise manner. First, the number of possible formations of blocks of four (including two people from the intervention group and two people from the control group) is determined, and from the six possible formations of these groups, 9 selections are made to ultimately have 9 blocks of four.The sequence of placement of individuals is determined based on these blocks and the names of the two groups are written on 36 cards based on the same random sequence and each is placed in a sealed envelope to ensure allocation concealment. After that, when the eligible individuals start to apply, the envelopes are opened in the order of their application and the group in which the individual is to be placed is determined, Blinding description: This study is a randomized double blind clinical trial. In this study, both groups of patients receive the main treatment, but in the intervention group, laser is used, while in the control group, we use a sham laser.The people who evaluate the patient are unaware of the assignment of people to groups. 3 Lichen planus. Intervention 1: Control Group : The Control group Patients receive mouthwash containing corticosteroid (0.5 mg of dexamethasone in 5 ml of water) as a standard first-line treatment; Then 30 minutes later, 100,000 units of nystatin solution is applied to prevent candidiasis. Treatment with mouthwash is done 4 times a day. In addition, patients are treated with sham photodynamic therapy. To carry out photodynamic therapy, the photosensitizer tolonium chloride is used on the lesion and 0.5 mm around the lesion using a sterile swab; Then, after 15 minutes, the lesion and 0.5 mm around the lesion a re exposed to sham laser (placebo) In a way that the patient is unaware laser unit is off due to wearing protective eyewear. In order to cover the entire parts of the lesion, in larger lesions, irradiation is performed in several points. In this study, lasotronix semiconductor diode laser (Warsaw, Poland) with a wavelength of 635 nm and a series diameter of 8 mm is used, and the duration of radiation at each point is 15 seconds (according to the manufacturer's instructions). According to the protocol presented in Sadaksharam's study, photodynamic therapy treatment is performed in 4 sessions on days 1, 4, 7 and 15. According to Sadaksharam's study, the follow-up sessions in this study are one week, two weeks, one month and two months after the start of intervention. Intervention 2: Intervention group: Patients in intervention groups receive mouthwash containing corticosteroid (0.5 mg of dexamethasone in 5 ml of water) as a standard first-line treatment; Then, 30 minutes later, 100,000 units of nystatin solution is applied to prevent candidiasis. Treatment with mouthwash is done 4 times a day. In addition, patients in the intervention group are treated with photodynamic therapy.To carry out photodynamic therapy, the photosensitizer tolonium chloride is used on the lesion and 0.5 mm around the lesion using a sterile swab; Then, after 15 minutes, the lesion and 0.5 mm around the lesion a re exposed to laser radiation. In order to cover the entire parts of the lesion, in larger lesions, irradiation is performed in several points. In this study, lasotronix semiconductor diode laser (Warsaw, Poland) with a wavelength of 635 nm and a series diameter of 8 mm is used, and the duration of radiation at each point is 15 seconds and the radiation power is 400 mW (according to the manufacturer's instructions). Laser radiation is done in contact mode.According to the protocol presented in Sadaksharam's study, photodynamic therapy treatment is performed in 4 sessions on days 1, 4, 7 and 15. According to Sadaksharam's study, the follow-up sessions in this study are one week, two weeks, one month and two months after the start of intervention. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identification. When: Access period starts 2 months after results are published To whom: The data is made available to anyone who needs this information. Conditions: Anyone who needs this data can email the main project manager and, if they agree, the data will be made available to them. Where to obtain: Faezeh Khozeimeh- khozeimeh@dnt.mui.ac.ir How to obtain: After sending an email to the main project manager and reviewing them, they can receive the information they need within a month. Comments:
public Faezeh Khozeimeh
School of Dentistry, Isfahan University of Medical Sciences, Hezarjrib Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5514 khozeimeh@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Faezeh Khozeimeh
School of Dentistry, Isfahan University of Medical Sciences, Hezarjrib Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5514 khozeimeh@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with ulcerative-erosive oral lichen planus, whose disease was confirmed by histopathological examination. no limit no limit Both Lesions that have evidence of dysplasia in the histopathological view contact or medicinal lichenoid lesions patients who have received oral treatment for their lichen planus during the last month pregnant and lactating patients people with uncontrolled systemic disease photosensitive people L43 Lichen planus Treatment - Devices Treatment - Devices Control Group : The Control group Patients receive mouthwash containing corticosteroid (0.5 mg of dexamethasone in 5 ml of water) as a standard first-line treatment; Then 30 minutes later, 100,000 units of nystatin solution is applied to prevent candidiasis. Treatment with mouthwash is done 4 times a day. In addition, patients are treated with sham photodynamic therapy. To carry out photodynamic therapy, the photosensitizer tolonium chloride is used on the lesion and 0.5 mm around the lesion using a sterile swab; Then, after 15 minutes, the lesion and 0.5 mm around the lesion a re exposed to sham laser (placebo) In a way that the patient is unaware laser unit is off due to wearing protective eyewear. In order to cover the entire parts of the lesion, in larger lesions, irradiation is performed in several points. In this study, lasotronix semiconductor diode laser (Warsaw, Poland) with a wavelength of 635 nm and a series diameter of 8 mm is used, and the duration of radiation at each point is 15 seconds (according to the manufacturer's instructions). According to the protocol presented in Sadaksharam's study, photodynamic therapy treatment is performed in 4 sessions on days 1, 4, 7 and 15. According to Sadaksharam's study, the follow-up sessions in this study are one week, two weeks, one month and two months after the start of intervention. Intervention group: Patients in intervention groups receive mouthwash containing corticosteroid (0.5 mg of dexamethasone in 5 ml of water) as a standard first-line treatment; Then, 30 minutes later, 100,000 units of nystatin solution is applied to prevent candidiasis. Treatment with mouthwash is done 4 times a day. In addition, patients in the intervention group are treated with photodynamic therapy.To carry out photodynamic therapy, the photosensitizer tolonium chloride is used on the lesion and 0.5 mm around the lesion using a sterile swab; Then, after 15 minutes, the lesion and 0.5 mm around the lesion a re exposed to laser radiation. In order to cover the entire parts of the lesion, in larger lesions, irradiation is performed in several points. In this study, lasotronix semiconductor diode laser (Warsaw, Poland) with a wavelength of 635 nm and a series diameter of 8 mm is used, and the duration of radiation at each point is 15 seconds and the radiation power is 400 mW (according to the manufacturer's instructions). Laser radiation is done in contact mode.According to the protocol presented in Sadaksharam's study, photodynamic therapy treatment is performed in 4 sessions on days 1, 4, 7 and 15. According to Sadaksharam's study, the follow-up sessions in this study are one week, two weeks, one month and two months after the start of intervention. Pain Score. Timepoint: Before starting intervention , one week, two weeks, one month and two months after starting intervention. Method of measurement: Visual Analogue Scale. Lesion size score. Timepoint: Before starting intervention, one week, two weeks, one month and two months after starting intervention. Method of measurement: Graded abslang. Esfahan University of Medical Sciences Approved 2025-05-07 Faculties of Dentistry, Health and Modern Medical Technologies, Isfahan University of Medical Scienc Hezarjrib Street, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)