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IRCT20180602039951N1 IRCT 2019-09-15 Dental School of Kerman University of Medical science Evaluation of therapeutic effect and placebo effect of low level laser therapy in temporomandibular disorders Evaluation of therapeutic effect and placebo effect of low level laser therapy in temporomandibular disorders 2019-09-06 anticipated 45 Complete https://irct.ir/trial/36721 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization will be done by computer software, patients will be divided to 3 groups, receptionist will extract patient's group and pass it to operator in sealed envelop. patients and doctors that evaluate treatment result will not be informed of patient's groups, Blinding description: patients: Blind interviewer: Blind therapist: Blind low level leaser machine operator: informed receptionist will extract patient's group and pass it to operator in sealed envelop. patients and their doctors will not informed. patients are blindfolded and beeping sound of machine is on for both groups. N/A temporomandibular disorders. Intervention 1: Intervention group 1: gallium–aluminum–arsenide, 808nm ، 300 mw، 3J/cm2 ، 10S 10 session ( twice a week for 5 weeks), 4 points around temporomandibular joint and every muscle trigger point in head and neck. Intervention 2: Intervention group: Intervention group 2 : using the same device that used in intervention group 1. Intervention in this group will be same as intervention group except that the device will be in active. Intervention 3: Control group: patients in this group will not face low level leaser therapy and will follow standard treatment protocol. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD, IPD collected for the primary outcome measure only When: 6 months after publication To whom: for people working in academic institutions or people working in businesses Conditions: people working in academic institutions Where to obtain: s.mafi@kmu.ac.ir Dr.Sahar Mafi How to obtain: requests containing how the data will be used must be applied via Email. Citation in future publication is mandatory. Data will be sent within 3 months. Comments:
public Sahar Mafi
Shafa Boulevard, Kerman, Kerman Province
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 s.mafi@kmu.ac.ir Kerman University of Medical Sciences scientific Sahar Mafi
Jomhouri Boulevard, Shafa Boulevard, Kerman Province, Kerman,
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 8074 s.mafi@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) acute and chronic myofascial pain ( muscle trigger point) TMJ tenderness without degenerative diseases limitation of mouth opening due to muscle pain or TMJ inflammation ability of reading and writing to answer questionnaires patient cooperation and compliance men and women between 15-60 years old 15 years 60 years Both using NSAID, corticosteroids,anti-convulsant, anti-psychotic, anti-depressant and narcotics mixed dentition developmental head and face deformity current orthodontic treatment, orthopedic appliance or splint therapy dental carries which replicated patient's pain in head and face partial or complete denture pregnancy and breast feeding history of pathological lesions in temporomandibular regions history of chemotherapy and radiotherapy of head and neck inability of answer to questionnaires periodontal diseases rheumatologic diseases Degenerative Joint Disease TMJ M26.6 Temporomandibular joint disorders Treatment - Devices Placebo Treatment - Other Intervention group 1: gallium–aluminum–arsenide, 808nm ، 300 mw، 3J/cm2 ، 10S 10 session ( twice a week for 5 weeks), 4 points around temporomandibular joint and every muscle trigger point in head and neck. Intervention group: Intervention group 2 : using the same device that used in intervention group 1. Intervention in this group will be same as intervention group except that the device will be in active. Control group: patients in this group will not face low level leaser therapy and will follow standard treatment protocol. Effect of low level leaser therapy on total trigger point score. Timepoint: Total trigger point score before intervention, and 1, 2, 3,4,5,weeks during intervention and one month after final intervention will be recorded. Method of measurement: head and neck muscles examination. Effect of low level leaser therapy on jaw sounds. Timepoint: before intervention, and 1, 2, 3,4,5,weeks during intervention. Method of measurement: Stethoscope. Effect of low level leaser therapy on jaw movement. Timepoint: before intervention, and 1, 2, 3,4,5,weeks during intervention. Method of measurement: ruler. Effect of low level leaser therapy on visual analog scale. Timepoint: before intervention, and 1, 2, 3,4,5,weeks during intervention. Method of measurement: visual analog scale. Dental School of Kerman University of Medical science Approved 2018-03-12 ethics committee of Kerman university of medical science Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)