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IRCT20130812014333N201 IRCT 2023-06-06 University faculty member Comparing the effectiveness of photodynamics with laser 810 by Indocyanine green with miconazole on denture stomatitis Comparing the effectiveness of photodynamics with laser810 by Indocyanine green with miconazole on denture stomatitis 2023-06-10 anticipated 40 Complete https://irct.ir/trial/70195 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, in addition to miconazole 2% gel that they receive 4 times a day for two weeks, Photodynamics is prepared with light-sensitive green indocyanine at a concentration of 1 mg/ml in sterile distilled water and will be stored in a dark place at room temperature until use.Then it is placed on the lesion of the palate with a sterile swab, after 10 minutes laser irradiation is performed by an experienced operator using an 810 nm diode laser. Intervention 2: The second intervention group will receive miconazole 2% gel 4 times a day for two weeks (with a cotton swab placed on the inner surface of the artificial tooth). For each use, 2.5 ml of gel is applied to the artificial tooth, which is immediately placed in. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Zahra Hadadian
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
Isfahan Iran (Islamic Republic of) 8155139998 +98 31 3535 4003 zakhma3008@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 - Other Treatment - Other In the first intervention group, in addition to miconazole 2% gel that they receive 4 times a day for two weeks, Photodynamics is prepared with light-sensitive green indocyanine at a concentration of 1 mg/ml in sterile distilled water and will be stored in a dark place at room temperature until use.Then it is placed on the lesion of the palate with a sterile swab, after 10 minutes laser irradiation is performed by an experienced operator using an 810 nm diode laser. The second intervention group will receive miconazole 2% gel 4 times a day for two weeks (with a cotton swab placed on the inner surface of the artificial tooth). For each use, 2.5 ml of gel is applied to the artificial tooth, which is immediately placed in. Fungal infection. Timepoint: The beginning and end of the study. Method of measurement: Examination and observation of the dentist. University faculty member Approved 2023-01-07 Ethics Committee of Islamic Azad University Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street Isfahan Isfehan Iran (Islamic Republic of)