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IRCT20190123042475N1 IRCT 2019-06-09 Bojnourd University of Medical Sciences Efficacy of a zinc mouthwash in prevention of head and neck radiotherapy-induced-oral mucositis: A double-blind randomized placebo-controlled trial Efficacy of a zinc mouthwash in prevention of head and neck radiotherapy-induced-oral mucositis: A double-blind randomized placebo-controlled trial 2019-04-21 anticipated 75 Complete https://irct.ir/trial/38102 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: This will be done for the first time in Iran, Randomization description: After random selection, each group will be identified based on the randomized table. In order to receive one of the interventions, they are randomly divided into permutational blocks. The radiotherapist is responsible for recording the degree of mucositis and the participants will not be informed of any grouping. Also, students who are responsible for completing the questionnaires are also unaware of the type of treatment interventions The physician who is aware of the study and the type of medication will be told the method of selecting and assigning samples based on a randomized table of numbers and each group will be followed up through random selection, Blinding description: This study was a cohort, double-blinded, randomized controlled clinical trial And will be performed on 75 patients who will be randomly assigned to three 25-patient groups of control or intervention. After completing the preparation of the products, the first performer places mouthwashes in 120-cc glasses for one week use of the patients and identifies them with codes A, B or C. The radiotherapists who are responsible for recording the degree of mucositis and the patient will not be aware of any groupings done. Also, the student responsible for completing the questionnaire is also unaware of the type of medical interventions Given the double-blindness of the study, the treatments will be covered in form A, B, C. The doctor who is aware of the study and the type of medication, will be told the method of selecting and assigning samples based on a randomized table of numbers and each group will be followed up through random selection. 3 oral mucositis. Intervention 1: Intervention group: 1% zinc sulfate, surfactant, and various suppositories (methyl cellulose, hydroxypropylmethyl cellulose, xanthan gum) will be used to prepare the mouthwash. The first presenter will put the mouthwash in the 120 cc glasses for one week consumption of the patient and they use the mouthwash 3 times a day, 5 cc each time for 6 weeks. Intervention 2: Control group: All components of the intervention group except zinc will be used to prepare the placebo mouthwash. The first presenter will put the mouthwash in the 120 cc glasses for one week consumption of the patient and they use the mouthwash 3 times a day, 5 cc each time for 6 weeks. Intervention 3: Control group: Prefabricated Chlorhexidine mouthwash( Vi-one 0/2% CHX) will put in the 120 cc glasses for one week consumption of the patient and they use the mouthwash 3 times a day, 5 cc each time for 6 weeks. 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 No more information
public Marzieh sahebnasagh
Faculty of Dentistry, Shahriar Blvd, next to Imam Ali Hospital, Bojnurd, Iran
Bojnurd Iran (Islamic Republic of) 9418654514 +98 98583272856 Marzieh.saheb@gmail.com Bojnourd University of Medical Sciences scientific Marzieh Sahebnasagh
Faculty of Dentistry, Shahriar Blvd, next to Imam Ali Hospital, Bojnurd, Iran
Bojnurd Iran (Islamic Republic of) 9418654514 +98 985832728568 Marzieh.saheb@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) All the cancer patients over 18 treated by radiotherapy 18 years no limit Both Incidence of co-existing systematic diseases ICD-70 Oral mucositis (ulcerative) Prevention Placebo Prevention Intervention group: 1% zinc sulfate, surfactant, and various suppositories (methyl cellulose, hydroxypropylmethyl cellulose, xanthan gum) will be used to prepare the mouthwash. The first presenter will put the mouthwash in the 120 cc glasses for one week consumption of the patient and they use the mouthwash 3 times a day, 5 cc each time for 6 weeks. Control group: All components of the intervention group except zinc will be used to prepare the placebo mouthwash. The first presenter will put the mouthwash in the 120 cc glasses for one week consumption of the patient and they use the mouthwash 3 times a day, 5 cc each time for 6 weeks. Control group: Prefabricated Chlorhexidine mouthwash( Vi-one 0/2% CHX) will put in the 120 cc glasses for one week consumption of the patient and they use the mouthwash 3 times a day, 5 cc each time for 6 weeks. Creating mucositis based on clinical manifestations (Clinical presentation), severity of mucositis based on the WHO benchmark. Timepoint: In the beginning of the study (before the onset of intervention), 1,2,3,4,5,6,7,8 weeks after commencing oral intake of zinc sulfate. Method of measurement: To test mucositis, the WHO classification system is divided into five degrees Grade 0 : None Grade 1 :Soreness + / - Erythema Grade 2 : Erythema , ulcer , patients can swallow solid diet Grade 3 : Ulcer , Extensive erythema , patients can not swallow solid diet Grade 4 : Mucositis to the extent that alimentation is not possible. Patients' quality of life and complications. Timepoint: at the beginning of the study (before the onset of intervention), 1,2,3,4,5,6,7,8 weeks after commencing oral intake of zinc sulfate. Method of measurement: Quality of life will also be measured using a questionnaire used in previous studies, which measures 0 to 4:Grade 0 (Complications have no effect on daily activities), Grade 1 (Symptoms cause discomfort at least once a week)Grade 2 (symptoms interact with your daily activities more than once a week), Grade 3 (symptoms also interfere with basic activities of life)Grade 4 (symptoms are such that the patient is afraid to leave the home, leading a sharp reduction in the individual's social activities. Bojnourd University of Medical Sciences Approved 2019-03-16 North Khorasan University of Medical Sciences Faculty of Dentistry, Shahriar Blvd, next to Imam Ali Hospital, Bojnurd, Iran Bojnurd North Khorasan Iran (Islamic Republic of)