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IRCT20180828040890N1 IRCT 2018-12-16 Iran University of Medical Sciences - Comparison the effect of mouthwash with water and licorice on dry mouth of dialysis patients Comparison the effect of mouthwash with pure water and licorice on dry mouth of hemodialysis patients 2018-07-23 anticipated 74 Complete https://irct.ir/trial/34581 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: In this study, patients were entered the study by available method and randomly divided into two groups (water, licorice) by block assignment. Thus, the letter A to water, the letter B, is assigned to licorice, and then possible conditions were written on cards and placed on the table. For each group, two of the patients who entered the study according to availability, a replacement card was taken by the researcher and placed in order of letters; the patients were divided in two groups. This process continued until the desired sample size was provided. 3 Dry mouth. The intervention group, used licorice and compare group used water at first 11 day. At this time each group used the solution 3 times (half an hour). After a meal, the mouthwash solution was taken and half an hour after the mouthwash, they do not eat anything and do not swallow mouthwash and they are thrown it out of mouth completely. The second 11 day, any mouthwash is used by the two groups. In the third stage of intervention mouthwash solution of two groups is displaced. Intervention group used water and compare group used licorice. Material used was licorice root powder that dissolved 5 grams per 500 cc in water and each time the solution was shaken to form a uniform solution. Licorice root is prepared by the expert of the traditional medicine pharmacist of the Faculty of Traditional Medicine, Dr. Ali Ghobadi, from Tehran's Great Market. In people with regime and absence of three main meals, is done three times mouthwash with an interval of 6-4 hours. Duration of mouthwash was two 11-days for each group and in second 11-day of study mouthwash with water and licorice, each group was completed Thomson's mouthwash questionnaire on fifth and eleventh day of the study. Yes - There is a plan to make this available What will be shared: The total potential data is being shared in non-identifiable condition When: After the publication of the paper resulted from the study To whom: Researchers and others Conditions: According to the study Where to obtain: Mail to the responsible for the trial update How to obtain: One week Comments:
public fesdeghchi Marzieh
Valiasr Street, Rashid Yasemi Street
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 8820 1987 fesdeghcji.m@tak.iums.ac.ir Iran University of Medical Sciences scientific Zhale mohammad-aliha
- Valiasr Street, Rashid Yasemi Street
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 8820 1978 mohammadaliha.j@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) People with advanced kidney failure undergoing regular hemodialysis (with the same weekly sessions) that complain of dry mouth in the last 4 weeks and have the ability to do mouthwash no limit no limit Both The patient's unwillingness to continue to participate in the study sensitivity to mouthwash licorice. Start medications that cause dry mouth during the study (Antihypertensive, antidepressant, diuretic, anticholinergic, and antihistamine) R68.2 خشکی دهان Prevention The intervention group, used licorice and compare group used water at first 11 day. At this time each group used the solution 3 times (half an hour). After a meal, the mouthwash solution was taken and half an hour after the mouthwash, they do not eat anything and do not swallow mouthwash and they are thrown it out of mouth completely. The second 11 day, any mouthwash is used by the two groups. In the third stage of intervention mouthwash solution of two groups is displaced. Intervention group used water and compare group used licorice. Material used was licorice root powder that dissolved 5 grams per 500 cc in water and each time the solution was shaken to form a uniform solution. Licorice root is prepared by the expert of the traditional medicine pharmacist of the Faculty of Traditional Medicine, Dr. Ali Ghobadi, from Tehran's Great Market. In people with regime and absence of three main meals, is done three times mouthwash with an interval of 6-4 hours. Duration of mouthwash was two 11-days for each group and in second 11-day of study mouthwash with water and licorice, each group was completed Thomson's mouthwash questionnaire on fifth and eleventh day of the study Thomson questionnaire Oral dry mouth score in 2014. Timepoint: At the study, on the fifth and eleventh day after using water and licorice. Method of measurement: Thomson Oral questionnaire 2014 For dry mouth, 5 questions include: 1- Feeling dry in my mouth 2- When I'm eating, I feel dry in my mouth,3- I have a feeling of dryness in the mouth when eating dry foods,4- I wake up at night for drinking 5- To swallow food, I should eat some water. Each answer is 5 questions using Likert 1- never 2- never ,hardly3- sometimes,4- frequently5- Always and the score of 25 is the highest score which shows the highest levels of dry mouth. And the 5 was lowest score without dry mouth. Iran University of Medical Sciences Approved 2017-07-17 Ethics Committee of Iran University of Medical Sciences Hemmat Highway, next to Milad Hospital and Razi congress center, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)