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IRCT20130812014333N203 IRCT 2023-07-18 University faculty member Comparing the efficacy of photodynamic laser 660 by methylene blue with photodynamic laser 810 by indocyanine green on denture stomatitis Comparing the efficacy of photodynamic laser 660 by methylene blue with photodynamic laser 810 by indocyanine green on denture stomatitis 2023-07-11 anticipated 40 Complete https://irct.ir/trial/71049 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code, Blinding description: Medications can only be identified by the serial number on the container. The serials are with the main doctor and will remain confidential until the end of the study. The charge of injecting medications will not know about the assignment of individuals to groups. The participants will not know about the allocation of study groups. Therefore, this study will be a double-blinded one. 2-3 Denture Stomatitis. Intervention 1: In the first intervention group, photodynamics will be sprayed by means of methylene blue with laser 660 twice a week for two weeks, on both the surface of the prosthesis and the palatal mucosa with light-sensitive methylene blue with a concentration of 450 μg/ml for 10 minutes before the irradiation. Intervention 2: In the second intervention group, photodynamics with laser 810 twice a week by green indocyanine will be prepared for two weeks with a concentration of 1 mg/ml in sterile distilled water and kept at room temperature until use. It should be applied on both the prosthesis and the palate mucosa surfaces with a sterile water swab. After 10 minutes, laser irradiation is performed by an experienced operator using an 810 nm diode laser. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mahsa Khodadadian
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
Isfahan Iran (Islamic Republic of) 8155139998 +98 31 3535 4003 mahsakh3076@gmail.com Islamic Azad University, Khorasgan branch scientific Dr. Amir Mansour Shirani
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
Isfahan Iran (Islamic Republic of) ۷۱۹۳۶۱۳۳۱۱ +98 31 3535 4003 amir.mansour.shirani@gmail.com Islamic Azad University, Khorasgan branch Iran (Islamic Republic of) Informed consent Patients with dentures and confirmed clinical evidence of denture stomatitis no limit no limit Both Patients with a history of diabetes, immunosuppression, radiotherapy, and chemotherapy Patients who have received antibiotics, antifungal drugs or steroids in the last 3 months K12.1 Other forms of stomatitis Treatment - Drugs Treatment - Drugs In the first intervention group, photodynamics will be sprayed by means of methylene blue with laser 660 twice a week for two weeks, on both the surface of the prosthesis and the palatal mucosa with light-sensitive methylene blue with a concentration of 450 μg/ml for 10 minutes before the irradiation. In the second intervention group, photodynamics with laser 810 twice a week by green indocyanine will be prepared for two weeks with a concentration of 1 mg/ml in sterile distilled water and kept at room temperature until use. It should be applied on both the prosthesis and the palate mucosa surfaces with a sterile water swab. After 10 minutes, laser irradiation is performed by an experienced operator using an 810 nm diode laser. The extent of red. Timepoint: The beginning of the study and the end of the study (two weeks later). Method of measurement: Using Visual Analogue Scale. Burning areas. Timepoint: The beginning of the study and the end of the study (two weeks later). Method of measurement: Using Visual Analogue Scale. University faculty member Approved 2023-01-07 Isfahan Branch (Khorasgan), Ethics Committee of Islamic Azad University Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street Isfahan Isfehan Iran (Islamic Republic of)