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IRCT20220930056061N1 IRCT 2023-07-29 Kerman University of Medical Sciences Effect of Pilocarpine mouthwash on diabetic patients xerostomia Evaluation of the effect of 0/3% Pilocarpine mouthwash on xerostomia in diabetic patients with xerostomia 2023-07-26 anticipated 80 Complete https://irct.ir/trial/66200 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization is done by simple randomization method. The desired method is done by punching 80 cards with the same appearance, which contain the necessary information to cooperate in the project along with the code related to the group of participants. According to the design of the study, 40 of the cards are coded as A and the other 40 are coded as B. In order to hide the random allocation, the cards are placed in the same opaque sealed envelopes, and after determining the group of each participant, the opened envelope is removed from the sequence. At the time of registration of eligible study participants and after obtaining informed consent, one of the envelopes is allocated to each person, which determines the participant's group. The sequence of random cards and the sealing of card envelopes are done by the researcher Mr. Mohammad Shayan Shakri, and in order to reduce the possible distortions caused by the knowledge of the researchers about the intervention groups, all researchers are blinded. Due to the cross-over design of the study, the randomization sequence was determined only for the initiation treatment, Blinding description: At the beginning of the study, 80 pieces of drug mouthwash (pilocarpine) and 80 pieces of placebo mouthwash that were prepared in the same color with the same taste and smell in the same packaging and volume were prepared in two separate groups to one person (from the employees of the oral diseases department of the Kerman Faculty of Dentistry) ), which is without profit and knowledge of the conditions and results of the study, is delivered, which are coded by them with arbitrary codes A and B. Allocation of mouthwash to the participants is done by randomization according to the mentioned method and based on the study design. All participating patients, clinical caregivers, researchers, outcome assessors and data analysts will not know the type of mouthwash used by people (medicinal or placebo) and the code related to the type of mouthwash. After the implementation and completion of the study and analysis of the results, the knowledgeable person responsible for coding the mouthwashes reveals the type of mouthwash corresponding to each code. 3 Dry mouth(xerostomia). Intervention 1: Intervention group: It is recommended for every person to keep 3 ml of 0/3% Pilocarpine mouthwash for 2 weeks in 3 meals a day (preferably after meals) in their mouth for 1 minute each time and then throw it away. Intervention 2: Control group: For 2 weeks, it is recommended for each person to use a placebo mouthwash consisting of the mouthwash excipients under study, which is prepared by essential oil in the same color with the same taste and smell in the same packaging and volume, in 3 meals a day (preferably after meals) ) and keep 3 ml in your mouth for 1 minute each time and then throw it away. Intervention 3: Control group: consists of the (remaining) people of the primary intervention group. due to the crossover design of the study, after the end of the washout period, it is recommended from each person of this group to take placebo mouthwash consisting of the excipients of the studied mouthwash which is prepared in same color, smell, essence in the same packaging and volume, for 2 weeks 3 meals a day (preferably after meals) and keep 3 ml in mouth for 1 minute each time and then throw it away. Intervention 4: Intervention group: consists of the (remaining) people of the primary control group. due to the crossover design of the study, after the end of the washout period, it is recommended from each person of this group to take Pilocarpine mouthwash for 2 weeks in 3 meals a day (preferably after meals) in their mouth for 1 minute each time and then throw it away. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohammad Shayan Shakeri
28th Alley, Shahid Sadooghi Blvd., Kerman, Iran
Kerman Iran (Islamic Republic of) 7618843663 +98 34 3213 4086 shayan.shakeri@yahoo.com Kerman University of Medical Sciences scientific Mohammad Shayan Shakeri
28th Alley, Shahid Sadooghi Blvd., Kerman, Iran
Kerman Iran (Islamic Republic of) 7618843663 +98 34 3213 4086 shayan.shakeri@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Having diabetes mellitus according to the diagnostic criteria of the American Diabetes Association Suffering from dry mouth according to the diagnosis based on the questionnaire of Fox et al desire and physical and mental ability to cooperate and use mouthwash correctly 18 years no limit Both History of uncontrolled asthma History of gastric ulcer Reluctance to cooperate with the study Acute or chronic use of medicine or mouthwash used to relieve dry mouth History of autoimmune disease Head and neck radiation therapy Infection with human immunodeficiency virus(HIV), hepatitis type B and hepatitis type C using of drugs effecting on the amount of saliva during the trial K11.7 Disturbances of salivary secretion Treatment - Drugs Placebo Placebo Treatment - Drugs Intervention group: It is recommended for every person to keep 3 ml of 0/3% Pilocarpine mouthwash for 2 weeks in 3 meals a day (preferably after meals) in their mouth for 1 minute each time and then throw it away. Control group: For 2 weeks, it is recommended for each person to use a placebo mouthwash consisting of the mouthwash excipients under study, which is prepared by essential oil in the same color with the same taste and smell in the same packaging and volume, in 3 meals a day (preferably after meals) ) and keep 3 ml in your mouth for 1 minute each time and then throw it away. Control group: consists of the (remaining) people of the primary intervention group. due to the crossover design of the study, after the end of the washout period, it is recommended from each person of this group to take placebo mouthwash consisting of the excipients of the studied mouthwash which is prepared in same color, smell, essence in the same packaging and volume, for 2 weeks 3 meals a day (preferably after meals) and keep 3 ml in mouth for 1 minute each time and then throw it away. Intervention group: consists of the (remaining) people of the primary control group. due to the crossover design of the study, after the end of the washout period, it is recommended from each person of this group to take Pilocarpine mouthwash for 2 weeks in 3 meals a day (preferably after meals) in their mouth for 1 minute each time and then throw it away. Unstimulated saliva volume of the sample. Timepoint: before the start of the intervention, and 14 and 35 days after using mouthwash. Method of measurement: Saliva draining method, which is one of the simple and practical methods of measuring the volume of non-irritating saliva in studies, in this method, the person is asked to first wash his mouth with distilled or deionized water to empty it of small debris, then swallow the remaining saliva in their mouth and rest for five minutes, then sit in a quiet environment free of factors that stimulate or limit the secretion of saliva, bend their head down and spit the saliva collected in their mouth for 5 minutes from their lower lip into a 50 ml graduated test container (which has been accurately weighed and sterilized). Intensity of xerostomia based on self-report of people. Timepoint: before the start of the intervention, and 14 and 35 days after using mouthwash. Method of measurement: Patients' self-reported questionnaire. Intensity of xerostomia based on Fox questionnaire. Timepoint: before the start of the intervention, and 14 and 35 days after using mouthwash. Method of measurement: Fox et. al questionnaire. Kerman University of Medical Sciences Approved 2023-02-13 Kerman University of medical science Kerman University of medical science research and technology department, Ebn e Sina Ave., Somayeh four-way Kerman Kerman Iran (Islamic Republic of)