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IRCT20190428043407N1 IRCT 2019-07-20 Tehran University of Medical Sciences Comparative effects of Vitamin E, Hyaloronic acid and Triamcinolone combination versus Triamcinolone alone on oral mucositis induced by radiotherapy Comparative effects of Vitamin E, Hyaloronic acid and Triamcinolone combination versus Triamcinolone alone on oral mucositis induced by radiotherapy 2019-07-23 anticipated 58 Complete https://irct.ir/trial/39231 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: The data required for the study are recorded in the forms provided by the moderator. Part of the information will be obtained by asking the patient and examining his case and the other part by the investigator's examination of the patient. Details are listed in the evaluation section of the study outcomes.Regular fast-tracking and daily follow-up through telephone calls increase patient adherence to proper protocol (oral maturation) and more confidence in the outcome. Failure to comply with medical orders of less than 70% and non-compliance with a visit of less than 70% will be considered as a deviation from the protocol. Data will be entered in the SPSS software without name and based on the code of the study. These data are provided to the statistical analyzer after determining whether each person belongs to one of the two groups without knowledge of the intervention or comparison of each group (by third party). * The method of analysis of the basic statistics related to The patient and the characteristics of the disease as well as the variables affecting the outcome of the study (probable confounders) are divided into two groups of study, to evaluate the accuracy of random allocation and the ability to compare the two groups.The percentage of mucositis intensity decreases qualitatively in two groups and will be compared with Chi-square statistical analysis. The severity of pain will be evaluated quantitatively after examining the data distribution with independent t-test or Mann-Whitney test. The frequency of complications in each group is reported by the Chi-square test (or Fisher test). The statistical significance is considered to be less than 0.05. More analyzes are performed after analyzing the primary and secondary consequences for the subgroup analyzes Will decide, Randomization description: The random allocation method will be based on the Balanced Block randomization method using the Microsoft Excel software. The number and size of blocks are determined by the individual. After the random allocation list has been obtained, on the mouthwash package (containing 4 glasses) and on the glass the consecutive numbers (from 1 to the final sample size) are written. A random assignment list is maintained in two versions and in two different locations by the person who generates the random allocation list until the data is analyzed. Randomization is done by an individual who is independent of the results and is not the beneficiary. The organizer of the plan is responsible for evaluating patients and forcing them to study and allocate interventions to them, Blinding description: In this study, the investigator (executor) responsible for administering interventions and the outcome of the outcome, the patients and the statistical analyzer of which patient are in the intervention group and which control group is not known, and only patient records recorded during the successive weeks 1 to 4 , In the form of groups A and B is provided to the analyzer (Triple Blind). 3 Oral mucositis induced by radiotherapy. Intervention 1: Intervention group: Treatment of patients with oral mucositis induced by head and neck radiotherapy by mouthwash contains of vit E , hyaluronic acid and triamcinolone. Intervention 2: Control group: Treatment of patients with oral mucositis induced by head and neck radiotherapy by triamcinolone mouthwsh. Yes - There is a plan to make this available What will be shared: After the data collection and completion of the study, the dissertation and the article will be displayed. When: Until the completion of the data collection To whom: The organizer collects the information plan as blind and analyzer analyses it blind and then By the third person, the results of the study will be specified. Conditions: It will be acceceble in the form of a paper for use and general application. Where to obtain: full professor.Dr. Farzaneh aghahoseini How to obtain: Search in the motor searches Comments: All of the above will be available upon completion of the research work
public FARZANEH AGHAHOSSEINI
Tehran University of Medical Sciences, High School of Dentistry, not reaching the exit of Hakim East, next to Atomic Energy Organization, End of North Worker Street
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5950 dentistry@tums.ac.ir Tehran University of Medical Sciences scientific FARZANEH AGHAHOSSEINI
Tehran University of Medical Sciences, High School of Dentistry, not reaching the exit of Hakim East, next to Atomic Energy Organization, End of North Worker Street
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5950 dentistry@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patient entry requirements include: Patients with (at least 18 years of age) (no maximum age limit, Patients with definite cervical cancer diagnosis according to histopathologic examination, Observe oral hygiene in a way that does not prevent the degree of mucositis severity, The patient has the ability to use mouthwash, Grade 3 and 4 oral mucositis according to WHO grade, No history of susceptibility to the drugs studied (so that patients are asked about drug sensitivities prior to entering the study and if they have not a history of hypersensitivity, they are included in the study, Signing consent form informed 18 years no limit Both Patient withdrawal criteria from the study include: Pregnant women who recently used (3 weeks) vitamin E and other supplemental antioxidants, Patients with other active oral lesions (such as major asthma), History of alcohol use, Drugs - Performing previous radiotherapy treatments and current chemotherapy treatments and bone marrow transplants with clinical, neurological, endocrine and other systemic diseases. Karnofsky performance status scale less than 60 (Patients in need of admission) K12.33 Oral mucositis (ulcerative) due to radiation Treatment - Drugs Treatment - Drugs Intervention group: Treatment of patients with oral mucositis induced by head and neck radiotherapy by mouthwash contains of vit E , hyaluronic acid and triamcinolone Control group: Treatment of patients with oral mucositis induced by head and neck radiotherapy by triamcinolone mouthwsh PAIN. Timepoint: weeks1,2,3,4. Method of measurement: Numerical pain scale. The rate of improvement in the severity of oral lesions. Timepoint: possible change of oral mucositis grade from 3 and 4 to steady levels. Method of measurement: WHO Grading. Type of prescription. Timepoint: weeks 1,2,3,4. Method of measurement: Based on the study method. Period of time. Timepoint: Date of referral of patients in weeks 1, 2, 3 and4. Method of measurement: Week 1 and 2, 3, and 4 Treatments. Gender. Timepoint: Date of referral of patients. Method of measurement: observation. Age. Timepoint: Date of referral of patients. Method of measurement: Ask the patient. Lack of the mouth wash tolerance is noted by patients and the study will be stopped if there are significant numbers of these people. Timepoint: weeks 1,2,3,4. Method of measurement: ask the patient. Tehran University of Medical Sciences Approved 2018-09-23 School of dentistry- Tehran University of Medical Sciences Tehran University of Medical Sciences, High School of Dentistry, not reaching the exit of Hakim East, next to Atomic Energy Organization, End of North Worker Street Tehran Tehran Iran (Islamic Republic of)