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IRCT20200411047026N1 IRCT 2020-05-11 Esfahan University of Medical Sciences Effect of low level laser therapy on paresthesia Evaluation of the of low-level laser photo biomodulation effect on enhancement of post Lefort I and sagittal split osteotomy surgery neurosensory deficits with clinical neurosensory testing (CNST) 2020-02-12 anticipated 12 Complete https://irct.ir/trial/47184 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 patients are treated unilateral with laser on and the other side with laser off without awareness of knowing the on or off of the device. Then after 1,3 months they are evaluated bilaterally with clinical neurosensory tests by the person who dont know about intervention or control side. N/A Condition 1: Post-orthognathic surgery paresthesia. Condition 2: Jaw deformity. Intervention 1: Intervention group: one side, called treated site will randomly choose 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 are 10 points in infra-orbital innervation entity between philtrum, lateral alar rim, lower lip, malar eminence and commissure lip line extension. exposure areas in mandible BSSO surgery are 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 Maryam Haghighat
No.81, Sharafaldin Ave., Shariati St.
Isfahan Iran (Islamic Republic of) 8173955161 +98 31 3627 0107 maryamhhh806@gmail.com Esfahan University of Medical Sciences scientific Maryam Haghighat
No.81,Sharafaldin Ave., Shariati St.
Isfahan Iran (Islamic Republic of) 8173955161 0098 32 36270107 maryamhhh806@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Healthy systemic status Age 18-30 Healthy neurological system informed consent 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 Taking muscle relaxant and sedative and anti-inflammatory drugs over the past 3 months Pregnancy Immune system defects Smoking Taking muscle relaxant and sedative and anti-inflammatory drugs over the past 3 months R20.2 M26 Paresthesia of skin Dentofacial anomalies [including malocclusion] Treatment - Devices Treatment - Devices Intervention group: one side, called treated site will randomly choose 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 are 10 points in infra-orbital innervation entity between philtrum, lateral alar rim, lower lip, malar eminence and commissure lip line extension. exposure areas in mandible BSSO surgery are 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. Thermal. Timepoint: Before surgery, 2 and 3 months after surgery. Method of measurement: Visual Analogue Scale. Light touch. Timepoint: Before surgery, 2 and 3 months after surgery. Method of measurement: Visual Analogue Scale. Pin prick. Timepoint: Before surgery, 2 and 3 months after surgery. Method of measurement: Visual Analogue Scale. Two point discrimination. Timepoint: Before surgery, 2 and 3 months after surgery. Method of measurement: caliper. Esfahan University of Medical Sciences Approved 2020-01-12 Ethics Committee of Isfahan University of Medical Sciences Hezarjarib St. Isfahan Isfehan Iran (Islamic Republic of)