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IRCT20120215009014N266 IRCT 2019-03-15 Hamedan University of Medical Sciences Effect of low level 940 nm diode laser therapy on pain, swelling and trismus after concomitant bilateral sagittal split osteotomy of mandibular ramus and Le Fort 1 osteotomy Effect of low level 940 nm diode laser therapy on pain, swelling and trismus after concomitant bilateral sagittal split osteotomy of mandibular ramus and Le Fort 1 osteotomy: a randomized clinical trial 2019-03-11 anticipated 30 Complete https://irct.ir/trial/38301 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the right and left sides of patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the right side of the patient will be assigned to that group and the opposite side to another group. N/A Limited mandibular range of motion. Intervention 1: Intervention group:Bilateral sagittal split osteotomy of mandibular ramus and Le Fort 1 osteotomy plus low level 940 nm diode laser therapy for at most 3 minutes. Intervention 2: Control group: Bilateral sagittal split osteotomy of mandibular ramus and Le Fort 1 osteotomy. 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 It depends on the situations and the results of the study as well as approval of the financial supporting organization.
public Navid Meimanat Abadi
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 Navid.meimanat@gmail.com Hamedan University of Medical Sciences scientific Dr. Mohamad Reza Jamalpour
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 jamalpour@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 65 years; Need for bilateral sagittal split osteotomy of mandibular ramus and Le Fort 1 osteotomy; Pulling out third molar 6 months ago 18 years 65 years Both A history of facial trauma; Disorder of inferior alveolar nerve; A history of gingivoplasty; Rapture of neurovascular bundle; A history of split surgery BSSO; Disorder of temporomandibular joint M26.52 Limited mandibular range of motion Treatment - Other Treatment - Other Intervention group:Bilateral sagittal split osteotomy of mandibular ramus and Le Fort 1 osteotomy plus low level 940 nm diode laser therapy for at most 3 minutes Control group: Bilateral sagittal split osteotomy of mandibular ramus and Le Fort 1 osteotomy Assessing the severity of pain. Timepoint: Immediately after surgery and then 72 hours and 1 and 2 and 4 weeks later. Method of measurement: By using the Visual Analog Scale. Assessing the severity of swelling. Timepoint: Immediately after surgery and then 72 hours and 1 and 2 and 4 weeks later. Method of measurement: through the physical examination. Assessing the severity of trismus. Timepoint: Immediately after surgery and then 72 hours and 1 and 2 and 4 weeks later. Method of measurement: Through the physical examination. Hamedan University of Medical Sciences Approved 2019-02-23 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)