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IRCT2012072410377N1 IRCT 2012-11-16 Baryj Essence Pharmaceutical Company Comparison the effect of Aloe Vera and Benzydamine hydrochloride mouth rinses on mucositis caused by radiation Comparison of aloe vera mouthwash and and Benzydamine Hydrochloride mouthwash on radiation induced mucositis in patients with head and neck cancer 2012-07-10 anticipated 26 Complete https://irct.ir/trial/10888 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Process of randomization: Pharmaceutical Company ” Barij Essence” will be packaged the mouth rinses into two quite similar bottles and will be send them to School of Dentistry, Tehran University of Medical Sciences. Two non-beneficiaries will label the bottles and then will give them to the Researcher. Without being aware about the mouth rinses ingredients, and just based on the ordering (numbers) The researcher will give the bottles to the patients. Patients will not aware about the content of the rinses either. In the consent form it is indicated that Rinses contain Benzydamine or Aloe Vera extract. Neither the researcher, nor the patients nor the statistical analyzer will be aware of the type of mouth rinses. 2 Mucositis. Intervention 1: Intervention: Aloe vera mouth rinse, chemical composition: Aloe vera gel 100%, concentration of 0.0009% Blue color Brilliant Blue, concentration of 0.0006% yellow color Tarterazine, manufacturer: Baryj Essence Pharmaceutical Company- During 6 weeks of Radiotherapy and up to 1 week after it, patients are asked to use 5 cc of mouth rinse 3 times a day, each time for 2 minutes and are avoid from eating and drinking for 30 minutes after using the mouth rinse. Intervention 2: Control: Benzydamine hydrochloride Mouth rinse, chemical composition: Benzydamine hydrochloride 0/15 %, manufacturer: pharmaceutical company Behvazan, brand: Behvazan 0/15% - During 6 weeks of Radiotherapy and up to 1 week after it, patients are asked to use 5 cc of mouth rinse 3 times a day, each time for 2 minutes and are avoid from eating and drinking for 30 minutes after using the mouth rinse.
public Doctor Arash Mansourian
Oral Medicine Department, school of Dentistry Tehran University of Medical Sciences، next to nuclear energy organization ، North Kargar Street، Tehran
Tehran Iran (Islamic Republic of) +98 21 8835 1152 aMansourian@tums.ac.ir School of Dentistry Tehran University of Medical Sciences, oral medicine Department scientific Doctor Mahnaz Saheb Jamee
Oral Medicine Department, school of Dentistry Tehran University of Medical Sciences, next to nuclear energy organization , North Kargar Street,Tehran
Tehran Iran (Islamic Republic of) +98 21 8835 1152 sahebjam@sina.tums.ac.ir School of Dentistry Tehran University of Medical Sciences, oral medicine Department Iran (Islamic Republic of) Inclusion criteria: Minimum age: 18 years, diagnosed cancer in the head and neck region, the minimum therapeutic dose of 50 Gy, oral cavity is placed in the radiation field, the patient's ability to cooperate and use medications as directed. Exclusion criteria: Patients with a history of cancer treatment during the last year, patients with a history of food allergy, oral lesions including active infection, mouth ulcers before starting the radiation therapy, lack of patient willingness and cooperation to participate in the study. 18 years 80 years Both L58.0 Acute radio dermatitis Prevention Prevention Intervention: Aloe vera mouth rinse, chemical composition: Aloe vera gel 100%, concentration of 0.0009% Blue color Brilliant Blue, concentration of 0.0006% yellow color Tarterazine, manufacturer: Baryj Essence Pharmaceutical Company- During 6 weeks of Radiotherapy and up to 1 week after it, patients are asked to use 5 cc of mouth rinse 3 times a day, each time for 2 minutes and are avoid from eating and drinking for 30 minutes after using the mouth rinse. Control: Benzydamine hydrochloride Mouth rinse, chemical composition: Benzydamine hydrochloride 0/15 %, manufacturer: pharmaceutical company Behvazan, brand: Behvazan 0/15% - During 6 weeks of Radiotherapy and up to 1 week after it, patients are asked to use 5 cc of mouth rinse 3 times a day, each time for 2 minutes and are avoid from eating and drinking for 30 minutes after using the mouth rinse. Mucositis grade. Timepoint: From Starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: questionnaire based on the Mucositis grade rating items from the World Health Organization (WHO). Mouth soreness. Timepoint: From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: Questionnaire (Asking from patient). Ulcer. Timepoint: From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: Questionnaire (Observation). Disability to swallowing solid food. Timepoint: From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: Questionnaire (Asking from patient). Disability to alimentation. Timepoint: From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: Questionnaire (Asking from patient). Erythema. Timepoint: From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: Questionnaire (Asking from patient and observation). Vice chancellor for research, school of Dentistry Tehran University of Medical Sciences Baryj Essence Pharmaceutical Company Vice chancellor for research, school of Dentistry Tehran University of Medical Sciences Approved 2012-07-23 Vice chancellor for research,Tehran University of Medical Sciences The Sixth Floor, central Organization of University, Keshavarz Blvd. Tehran Iran (Islamic Republic of)