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IRCT2015112123529N1 IRCT 2015-11-21 Vice chancellor for research, Kerman University of Medical Sciences anesthetics effect of mouth wash Amitriptyline Evaluation of the effect of niosomal mouth wash Amitriptyline as local anesthetics in patients with oral mucositis due to radio therapy or chemo therapy and comparison with mouth wash Benzydamine HCl 2014-03-20 anticipated 60 Complete https://irct.ir/trial/20046 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: sealed envelopes will used to allocation group randomisation. N/A Anaesthesia. Intervention 1: intervention group1: niosomal mouth wash Amitriptyline(Manufacturer: Darou Pakhsh Pharmaceutical Mfg Co.) ,15 cc for 30 seconds qd. Intervention 2: intervention group2: mouth wash Amitriptyline(Manufacturer: Darou Pakhsh Pharmaceutical Mfg Co.),15 cc for 30 seconds qd. Intervention 3: control group: mouth wash Benzydamine HCl(Manufacturer: Darou Pakhsh Pharmaceutical Mfg Co.),15 cc for 30 seconds qd.
public Dr. Elahe Tahmasebi
Dentistry School, Shafa St.
Kerman Iran (Islamic Republic of) +98 34 3213 3454 e_tahmasbi@collegian.kmu.ac.iR; elahe.tahmasebi.delfan@gmail.com Kerman University of Medical Sciences scientific Dr. Shahla Kakoei
Dentistry School, Shafa St.
Kerman Iran (Islamic Republic of) +98 34 3211 9028 Skakoei@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) inclusion criteria: patients with oral mucositis due to radiotherapy or chemotherapy; having pain or burning mouth while study. exclusion criteria: allergic to three-cyclic antidepressants. no limit no limit Both F44.6 Dissociative anaesthesia and sensory loss Treatment - Drugs Treatment - Drugs Treatment - Drugs intervention group1: niosomal mouth wash Amitriptyline(Manufacturer: Darou Pakhsh Pharmaceutical Mfg Co.) ,15 cc for 30 seconds qd intervention group2: mouth wash Amitriptyline(Manufacturer: Darou Pakhsh Pharmaceutical Mfg Co.),15 cc for 30 seconds qd control group: mouth wash Benzydamine HCl(Manufacturer: Darou Pakhsh Pharmaceutical Mfg Co.),15 cc for 30 seconds qd Severity. Timepoint: befor intervention and in 1, 5, 10, 30 and 60 minutes after intervention. Method of measurement: VAS form. -. Timepoint: -. Method of measurement: -. Vice chancellor for research, Kerman University of Medical Sciences Approved 2014-09-23 Ethics committee of Kerman University of Medical Sciences Vice chancellor for research Building, Jihad st. Kerman Iran (Islamic Republic of)