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IRCT20080906001216N3 IRCT 2020-06-14 vice chancellor of reasearch of Mashhad University of medical sciences The effect of laser on radiation-induced xerostomia in patients with head and neck cancer Evaluation the preventive effects of low level laser in head and neck radiotherapy induced xerostomia-a clinical trial 2018-04-04 anticipated 34 Complete https://irct.ir/trial/430 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Blinding description: In this study, patients do not know whether the laser is on or off. a unique laser system is used in both groups. two groups never meet each other . all protocols are similar.laser safety actions are similar in both groups.in sham laser group a beep sound is played by mobile so that the patint per cive switching the laser beam while le has safety goggles and tha mobile is not in visual field. in laser group the system is really switched on and off. N/A Radiation-induced xerostomia. Intervention 1: Intervention group: GaAlAs Low level laser (LLL ) with 810 nm, 200 mw power,3 cm penetration depth using dose 2 j/cm2 ,on 16 points including: 3 points on each parotid gland,2 points on each sublingual gland,1 point on each sublingual gland and 2 points on each buccal mucosa by continuous wave and contact mode. Intervention 2: Control group: The laser device is used off. Yes - There is a plan to make this available What will be shared: Some data including demographic properties, signs and symptoms When: One months after article publication. To whom: Academic researchers Conditions: It is permitted to use the data in other studies with reference. Where to obtain: Dr Pegah Mosannen Mozafari e-mail: Mosannenp@mums.ac.ir How to obtain: Sending email to authors. the authors will send data via email during 3 weeks Comments:
public Mahdokht Rashed Mohasel
Mashhad Dentistry School
Mashhad Iran (Islamic Republic of) 9177948959 +98 517674255 mahdokht_65@yahoo.com Mashhad Dentistry School scientific Zahra Delavarian
Mashhad Dentistry School
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3891 1421 delavarianz@mums.ac.ir Mashhad Dentistry School Iran (Islamic Republic of) Age range:20-75 Yrs Suffering from head and neck tumors requiring radiotherapy Involving one of major salivary glands in radiation field Total dose exceeding 20 Gry 20 years 75 years Both Patient or physician dissatisfaction Suffering from minor or major salivary gland tumors Suffering from any systemic disease with potential of xerostomia or consumption of any drug causing xerostomia Presence of xerostomia in initial examination(unstimulated saliva<0.1 ml/min) History of previous radiotherapy Presence of oral mucosal lesions Regration of patient during trial R68.2 Dry mouth, unspecified Prevention Placebo Intervention group: GaAlAs Low level laser (LLL ) with 810 nm, 200 mw power,3 cm penetration depth using dose 2 j/cm2 ,on 16 points including: 3 points on each parotid gland,2 points on each sublingual gland,1 point on each sublingual gland and 2 points on each buccal mucosa by continuous wave and contact mode. Control group: The laser device is used off Stimulated and unstimulated saliva. Timepoint: before radiotherpay and once weekly during radiotherpay ( mean: 6 weeks) on 8 to 10 a.m. Method of measurement: Unstimulated saliva: during 5 minutes,whole saliva was sputed in glass tube (every 60 minutes , 5 times).saliva was measured in mili liters and grams stimulated saliva: saliva stimulation in 0,30,60,90 and 120 seconds by citric acid 2% soaked swab on lateral borders of tongues. vice chancellor of reasearch of Mashhad University of medical sciences Approved 2015-06-20 research ethics committee of Mashhad university of medical sciences vice chancellor of research of Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)