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IRCT20230923059490N1 IRCT 2023-10-01 Shahid Beheshti University of Medical Sciences Evaluation of the effects of photobiomodulation therapy on oral ulcers induced by radiotherapy Evaluation the Efficacy of Photobiomodulation Therapy with 660 nm Diode Laser on Treatment of Radiotherapy- Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial 2023-11-22 anticipated 30 Complete https://irct.ir/trial/72772 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will generate random numbers using the Random Number Generation command in Excel. If these generated numbers are even, the patient is assigned to the intervention group, and if it is odd, the patient is assigned to the control group.Each of the groups to which 15 patients are compleieted, the generated numbers corresponding to that group are removed from the random numbers, Blinding description: 1. Patients: For all patients in both intervention and control groups photobiomodulation therapy with a diode laser will be done, but in the control group laser will be in off mode, and patients can't recognize the on or off status of the laser device due to wearing laser safety goggles. 2. Outcome assessor: the outcome assessor will be blind to the type of treatment that patients have received. N/A Oral mucositits induced by radiotherapy to head and neck. Intervention 1: Intervention group: patients with oral mucositis receiving photobiomodulation therapy with low level 660 nm diode laser. Intervention 2: Control group: Patients with oral mucositis receving sham photobiomodulation therapy (laser in off mode). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Neda Hakimiha
Shohadaye- Tajrish Hospital, ĜŒTajrish square
Tehran Iran (Islamic Republic of) 1989934370 +98 21 2274 9221 ned.hakimiha@gmail.com Shahid Beheshti University of Medical Sciences scientific Neda Hakimiha
Shohadaye- Tajrish Hospital, Tajrish Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1989934370 +98 912 396 4604 ned.hakimiha@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with equal or more than 60% Karnofsky Performance Status Life expectancy equal or more than 3 months Clinical confirmation of oral mucositis with minimum grade 1 18 years no limit Both Previous history of radiotherapy to head and neck region Other systemic diseases K12.33 Oral mucositis (ulcerative) due to radiation Treatment - Devices Treatment - Devices Intervention group: patients with oral mucositis receiving photobiomodulation therapy with low level 660 nm diode laser Control group: Patients with oral mucositis receving sham photobiomodulation therapy (laser in off mode) Oral mucositis grade measured by WHO scale. Timepoint: Before intervention, during treatment session , 4 weeks after intervention. Method of measurement: WHO (World Health Organization) grading Scale for oral mucositis. Shahid Beheshti University of Medical Sciences Approved 2023-08-09 Ethics committee of laser application in medical sciences reseaerch center, shahid behe Shohadaye tajrish hospital, Tajrish square. Tehran Tehran Iran (Islamic Republic of)