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IRCT20230625058578N1 IRCT 2023-08-18 Artesh University of Medical Sciences Investigating the effect of suckable form of curcumin and ginger mouthwash on oral health and sense of taste Comparison of the effect of curcumin suck able form and ginger mouthwash on oral health and sense of taste in hemodialysis patients 2023-07-23 anticipated 99 Complete https://irct.ir/trial/70915 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is a block randomization in blocks of six, which will be assigned to three intervention groups: ginger mouthwash, curcumin lozenge form, and control group. The randomization unit is individual. The randomization tool is web-based randomization. A block method with a volume of 6 is used to create a random allocation sequence. According to the total number of samples required for the study, which is 99 patients (two intervention groups A, B and control group C), a block of 6 including three groups A, B and C will be randomly designed through the software and then based on the sample size , 99 envelopes (33 envelopes containing paper containing A) and (33 envelopes containing paper containing B and (33 envelopes containing paper C) are prepared. Based on the list of six randomly prepared blocks, a trained person is responsible for allocating patients as It is random, after each patient is admitted to the ward, according to the block of six prepared in the first stage, each patient will be randomly placed in the intervention group (A and B) or the control group (C), and the sample process will be consecutive until the sample is completed. people will be assigned to the desired group in the order of their entry into the study and randomly through randomized blocks. The method of concealment is the use of Sequentially numbered, sealed opaque. 1-2 oral hygiene. Intervention 1: In the intervention group: in the ginger mouthwash group, patients use mouthwash in the morning and at night for 30 seconds to one minute inside the mouth according to the mouthwash instructions, i.e. 5-10 cc. Oral and dental hygiene, including dental floss, how to brush teeth, washing the mouth after every meal, teaching how to use mouthwash and suction form, were taught by the main researcher and the main researcher's associate nurse in the dialysis department, and all clients are asked to They should brush their teeth twice a day, the necessary supervision to do the work is done by the main researcher and through education to the families. None of the participants have dietary restrictions for this study and they continue to eat and maintain oral hygiene according to the routine of dialysis patients. The BOAS scale in each of these two groups is checked before the start of the study and after the completion of the study, after 1 month, and the patients' sense of taste is subjectively asked. Intervention 2: In the intervention group, the lozenges form of curcumin is used in the form of two in the morning and two in the evening. Oral and dental hygiene includes dental floss, how to brush your teeth, rinsing the mouth after every meal, training in the use of the lozenges form, by the researcher. The principal and the associate nurse of the principal researcher have been trained in the dialysis department and all patients are asked to brush their teeth twice a day. None of the participants have dietary restrictions for this study and they continue to eat and maintain oral hygiene according to the routine of dialysis patients. The BOAS scale in each of these two groups is checked before the start of the study and after the completion of the study, after 1 month, and the patients' sense of taste is subjectively asked. Intervention 3: Control group: In the control group, no medication is given and the routine care provided to the dialysis patients will continue. None of the participants have dietary restrictions for this study, and according to the routine of the dialysis patients, they continue with nutrition and oral hygiene. . The BOAS scale in each of these two groups is checked before the start of the study and after the completion of the study, after 1 month, and the patients' sense of taste is subjectively asked. Yes - There is a plan to make this available What will be shared: Information about the effectiveness of the study includes the effect of the main outcome. When: The access period starts 6 months after the results are published To whom: Everyone can apply to receive Conditions: Any request is allowed. Where to obtain: Information is through email addresses and phone numbers. Mr. Alireza Hosseini 09123054946 How to obtain: Send the request by phone or email and check the request by the author and then answer the request to the requester within 72 hours. Comments:
public foroozeh mehrabi
etemadzadeh street
tehran Iran (Islamic Republic of) 8784488447 +98 21 8609 6350 f_mehrabi@ajaums.ac.ir Artesh University of Medical Sciences scientific fatemeh kalroozi
kaj street
tehran Iran (Islamic Republic of) 8777601533 +98 21 7750 0909 fkalroozi@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years of age Patients who They undergo dialysis three days a week and dialysis adequacy (Kt/V) is normal. Mental and physical ability to use mouthwash and suction form Being healthy and not having wounds or skin disease in the mouth and face area Persons who have a score of more than 6 in the BIOS scale review 18 years 75 years Both 1. Use of anti-inflammatory substances by hemodialysis patients in the past six weeks and at the time of examination Antibiotic use Having immune system deficiency Suffering from blood platelet deficiency Suffering from acute systemic diseases Acute oral and dental infection History of allergy to ginger and turmeric Drug addiction Suffering from mental and cognitive diseases that make it impossible to communicate with the patient Medical problems such as history of radiotherapy, Sjogren's syndrome and the use of drugs that affect salivary glands and their secretion Suffering from diabetes in those seeking help who take the inhaled form of curcumin People whose sense of taste has been lost during another special disease (coronavirus patients, etc.) Using mouthwash or artificial saliva Prevention Prevention Other In the intervention group: in the ginger mouthwash group, patients use mouthwash in the morning and at night for 30 seconds to one minute inside the mouth according to the mouthwash instructions, i.e. 5-10 cc. Oral and dental hygiene, including dental floss, how to brush teeth, washing the mouth after every meal, teaching how to use mouthwash and suction form, were taught by the main researcher and the main researcher's associate nurse in the dialysis department, and all clients are asked to They should brush their teeth twice a day, the necessary supervision to do the work is done by the main researcher and through education to the families. None of the participants have dietary restrictions for this study and they continue to eat and maintain oral hygiene according to the routine of dialysis patients. The BOAS scale in each of these two groups is checked before the start of the study and after the completion of the study, after 1 month, and the patients' sense of taste is subjectively asked. In the intervention group, the lozenges form of curcumin is used in the form of two in the morning and two in the evening. Oral and dental hygiene includes dental floss, how to brush your teeth, rinsing the mouth after every meal, training in the use of the lozenges form, by the researcher. The principal and the associate nurse of the principal researcher have been trained in the dialysis department and all patients are asked to brush their teeth twice a day. None of the participants have dietary restrictions for this study and they continue to eat and maintain oral hygiene according to the routine of dialysis patients. The BOAS scale in each of these two groups is checked before the start of the study and after the completion of the study, after 1 month, and the patients' sense of taste is subjectively asked. Control group: In the control group, no medication is given and the routine care provided to the dialysis patients will continue. None of the participants have dietary restrictions for this study, and according to the routine of the dialysis patients, they continue with nutrition and oral hygiene. . The BOAS scale in each of these two groups is checked before the start of the study and after the completion of the study, after 1 month, and the patients' sense of taste is subjectively asked. Oral hygiene. Timepoint: before the intervention, immediately after the intervention and after 1 month after the end of the intervention. Method of measurement: Beck oral health assessment scale. Sense of taste. Timepoint: before the intervention, immediately after the intervention and after 1 month after the end of the intervention. Method of measurement: Subjective scale of sense of taste. Artesh University of Medical Sciences Approved 2023-06-19 Ethics Committee of Tehran Army University of Medical Sciences Pirouzi St. - Abuzar Blvd. - North Rabzah St. - 22 Alley, No. 29, Unit 1 Tehran Tehran Iran (Islamic Republic of)