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IRCT20180826040863N1 IRCT 2018-12-03 Rasht University of Medical Sciences Effectiveness of Diode low-level laser therapy on treatment of mucositis induced by chemoradiotherapy in H&N cancer patients referring to Guilan(Rasht) dental college:A single- blind randomized clinical trial Effectiveness of Diode low-level laser therapy on treatment of mucositis induced by chemoradiotherapy in H&N cancer patients referring to Guilan(Rasht) dental college:A single- blind randomized clinical trial 2018-07-16 anticipated 36 Complete https://irct.ir/trial/33928 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random numbers table, Blinding description: In this study, only participants are unaware of the allocation of study groups. 3 oral mucositis. Intervention 1: Control group: combined mouthwash: kept the mouthwash of Diphenhydramine + Almgs (50-50 in combination) at 15 ml every 6 hours for 30 seconds in the mouth and then spitting. Intervention 2: Intervention group: low_level Diode laser:The laser is applied in mucositis areas with a wavelength of 810 nm and a time of 30 seconds per 1 cm2. No - There is not a plan to make this available Justification or reason for not sharing IPD is preserve Secrets of the patients
public Shadi Barati
Ansarieh
Zanjan Iran (Islamic Republic of) 4515755589 +98 13 3348 6416 shadi.barati1373@gmail.com Rasht University of Medical Sciences scientific Safa Motevasseli
End of Lacan Road - 2 Km to Fouman - Facing Caspian Restaurants and Facade - University of Guilan University of Medical Sciences
Rasht Iran (Islamic Republic of) 4194173774 +98 13 3348 6416 smotevasselee@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Head and neck cancer Receiving Chemotherapy and Radiation Therapy Getting oral mucositis stage3,4 no limit no limit Both Restricted opening of the mouth (less than 1cm2) that does not allow the use of laser on the tissue. Relapse during treatment Taking any medication to prevent and treat mucositis Failure to perform mucositis treatment process Inability to observe oral hygiene K12.3 Oral mucositis (ulcerative) Treatment - Drugs Treatment - Devices Control group: combined mouthwash: kept the mouthwash of Diphenhydramine + Almgs (50-50 in combination) at 15 ml every 6 hours for 30 seconds in the mouth and then spitting Intervention group: low_level Diode laser:The laser is applied in mucositis areas with a wavelength of 810 nm and a time of 30 seconds per 1 cm2 The amount of pain. Timepoint: Laser: From the onset of the lesion / Day 4 ofTreatment / One week after treatment. mouthwash: From the beginning of the lesion for one month. Method of measurement: Based on the VAS index. Severity of lesion. Timepoint: Laser: From the onset of the lesion / Day 4 ofTreatment / One week after treatment. mouthwash: weekly From the beginning of the lesion for one month. Method of measurement: Based on the WHO. Length of treatment. Timepoint: Sum of Severity of Mucositis Severity of Days from the onset of symptoms of grade 3 and 4. Method of measurement: number of days. Quality of life. Timepoint: Laser: From the onset of the lesion / Day 4 ofTreatment / One month after treatment. mouthwash:weekly From the beginning of the lesion for one month. Method of measurement: based on FACT_HN & OMWQ _ HN. Rasht University of Medical Sciences Approved 2018-06-11 Ethics Committee of Guilan University of Medical Sciences Research Center End of the Lacan Road - 2 Km to Fouman - Facing Caspian Restaurants and Facade - University Complex in Guilan University of Medical Sciences Rasht Guilan Iran (Islamic Republic of)