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IRCT20191228045909N1 IRCT 2020-03-02 Esfahan University of Medical Sciences Effect of low level laser therapy on paresthesia Evaluation of the low level laser photobiomodulation effect on post Lefort I and sagittal split osteotomy surgery neurosensory deficits enhancement with quantitative electrodiagnostic neurosensory test (blink reflex) 2020-02-12 anticipated 12 Complete https://irct.ir/trial/45246 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: surgical areas (left or right) in each jaws (maxilla and mandible) are randomly divided into two groups (intervention and control) by coin flipping method, Blinding description: Each operated jaws of the patients (maxilla or mandible) are randomly divided to right and left sides as intervention or control side (with coin flip) then the patienst are treated unilateral with laser on and the otherside with laser off without awareness of knowing the on or off of the device. then after 2,3 months they are evaluated bilaterally by the EMG technician without knowing the treated or placebo sides. N/A Condition 1: Post-orthognathic surgery paresthesia. Condition 2: Jaw deformity. Intervention 1: Intervention group: one side, called treated site was randomly chosen for low level laser therapy by portable device (GaAlAs) in day 1, 5, 10 and 14 after orthognathic surgery. Exposure areas in lefort I candidates were 10 points in infra-orbital innervation entity between philtrum, lateral alar rim, lower lid, malar eminence and commissure lio line extension. exposure areas in mandible BSSO surgery were 7 points in IAN canal line between angle to menton (linear and 1 cm apart) and 9 points in mental erea (between mental foreman to midline). Intervention 2: Control group: Orthognathic surgery without laser exposure. In the control group (other side) the device is in stand-by mode with no exposure (placebo effect) and the same points with the same duration are pretending to be irradiated as the treated side. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Alireza Tamizifar
No. 5, Pasandideh Ave, East Allame Amini Blvd, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8158935181 +98 31 3260 0885 alirezatamizifar@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Alireza Tamizifar
No. 5, Pasandideh Ave, East Allame Amini Blvd, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8158935181 +98 31 3260 0885 alirezatamizifar@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) healthy systemic status age 18-30 healthy neurological system Signature of consent form Patients candidate for orthognathic surgery 18 years 30 years Both Any local or systemic disease age under 18 and over 30 years history of trauma and jaw fracture history of previous maxillofacial surgery Undesirable splint during operation Pregnancy Immune system defects smoking Taking muscle relaxant and sedative and anti-inflammatory drugs over the past 3 months Failure to attend follow-up sessions R20.2 M26 Paresthesia of skin Dentofacial anomalies [including malocclusion] Treatment - Devices Treatment - Devices Intervention group: one side, called treated site was randomly chosen for low level laser therapy by portable device (GaAlAs) in day 1, 5, 10 and 14 after orthognathic surgery. Exposure areas in lefort I candidates were 10 points in infra-orbital innervation entity between philtrum, lateral alar rim, lower lid, malar eminence and commissure lio line extension. exposure areas in mandible BSSO surgery were 7 points in IAN canal line between angle to menton (linear and 1 cm apart) and 9 points in mental erea (between mental foreman to midline). Control group: Orthognathic surgery without laser exposure. In the control group (other side) the device is in stand-by mode with no exposure (placebo effect) and the same points with the same duration are pretending to be irradiated as the treated side.. The mean latency of R1, R2 and R2' (msec) in blink reflex electromyography. Timepoint: Before surgery, 2 and 3 months after surgery. Method of measurement: Blink reflex electromyography. Esfahan University of Medical Sciences Approved 2020-01-07 Ethics Committee of Isfahan University of Medical Sciences Hezar Jerib Ave Isfahan Isfehan Iran (Islamic Republic of)