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IRCT20210429051121N1 IRCT 2021-11-29 Mazandaran University of Medical Sciences Evaluation of the effect of a mouthwash containing sumac extract on patients with denture stomatitis Comparison of the therapeutic effect of mouthwash containing sumac extract and nystatin suspension in patients with denture stomatitis 2021-09-27 anticipated 22 Complete https://irct.ir/trial/58789 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, individuals with complete maxillary denture with denture stomatitis (type II and III) referred to the Clinic of Sari Dental School are examined. First, the presence of denture stomatitis in patients is confirmed by an oral specialist, and then, if the patient wishes and the consent form are signed, patients will enter the study. In addition, patients do not know which treatment group they belong to and will be randomly assigned to two groups, Randomization description: In this study, participants will be randomly assigned to two groups using the Balanced Block Randomization. From 6 possible modes for 4 blocks including two participant from the intervention group and two participant from the control group using the RANDBETWEEN command in Excel software, 6 blocks will be selected randomly and a random sequence will be created. According to the random sequence, Participants will be divided into intervention and control groups. Randomization will be performed by the statistics consultant. Also, random sequences concealment for each participant will be done by the supervising dentist, Blinding description: This study is a randomized double blind clinical trial and patients and examiners and therapists will not be aware of the type of drug used and the type of study group. 0 (exploratory trials) Denture stomatitis - severe palate infection. Intervention 1: Intervention group: Sumac mouthwash will be gargled 3 times a day (20 drops each time). Intervention 2: Control group: Nystatin 100000u / ml mouthwash will be gargled 3 times a day (20 drops each time). Yes - There is a plan to make this available What will be shared: After the publication of the article from the present clinical trial, all information will be available as long as the identities of the study participants remain confidential. When: After completing the phases of the clinical trial and publishing the article resulting from this clinical trial in a journal, information will be available to all eligible individuals. To whom: All researchers from a reputable scientific organization can request information. Conditions: All researchers from a reputable scientific organization can request information. Where to obtain: Applicants can request more information via e-mail with Dr. Maedeh Salehi. How to obtain: All applicants must have valid documents of cooperation with reputable organizations and universities of medical sciences and submit them to Dr. Maedeh Salehi. Then their request will be reviewed and if the documents are valid, they will cooperate. Comments:
public Maede Salehi
Touba Dental Clinic, Khazar Boulevard, Sari, Mazandaran, Iran.
Sari Iran (Islamic Republic of) 4818813965 +98 11 3324 4894 am.shafaroudi@gmail.com Mazandaran University of Medical Sciences scientific Maede Salehi
Touba Dental Clinic, Khazar Boulevard, Sari, Mazandaran, Iran.
Sari Iran (Islamic Republic of) 4818813965 +98 11 3324 4894 am.shafaroudi@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients referred to the clinic of Sari Dental School due to maxillary complete denture Patients with denture stomatitis (type II and III) with confirmation of denture stomatitis in patients by an oral pathologist no limit no limit Both Patients with a history of using antifungal drugs, antibiotics and corticosteroids in a last month, Allergy to nystatin mouthwash, Patients with immunodeficiency, Alzheimer's, psychological disorders, chewing muscle disorder, Patients with inability to use mouthwash and patients with loose and discolored dentures, Treatment - Drugs Treatment - Drugs Intervention group: Sumac mouthwash will be gargled 3 times a day (20 drops each time) Control group: Nystatin 100000u / ml mouthwash will be gargled 3 times a day (20 drops each time). Size of denture stomatitis lesions before and after using Sumac mouthwash and nystatin mouthwash. Timepoint: Patients are asked to hold the mouthwash in their mouth for 1 minute and to avoid eating and drinking for at least 1 hour after using the mouthwash. Treatment will continue for 2 weeks and erythematous lesions will be checked weekly. Method of measurement: The length and width of erythematous lesions in the area under the denture are assessed by a calliper and by a specialist on a centimeter basis. Photographic waste will also be prepared each week. At the beginning and end of the study, smear and culture (Sabouraud's dextrose agar) will be prepared from the infected area of ​​the palate. Patients and examiners will not be aware of the type of drug used and the type of study group. In physiological serum in a numbered test tube, the lesion surface was sampled. Then, saliva and plaque samples were immediately transferred to the specialized laboratory of Mazandaran Science and Technology Park for mushroom cultivation and immediately cultured in Saburodextrose agar solid medium next to the flame and under the hood. Mazandaran University of Medical Sciences Approved 2017-06-25 Ethics Committee of Mazandaran University of Medical Sciences Vice-Chancellor of Research, Mazandaran University of Medical Sciences, Moallem Square, Sari, Mazandaran, Iran. Sar Mazandaran Iran (Islamic Republic of)