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IRCT20200520047519N1 IRCT 2020-06-09 Kerman University of Medical Sciences Evaluation of effect of laser on TMJ fracture Double blind randomized clinical trial of therapeutic effect of low level laser therapy on acute pain and mouth openning after closed redution of condylar fracture. 2020-06-21 anticipated 40 Complete https://irct.ir/trial/48293 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed utilizing computer software using block randomization method and 5 patient within a block, Blinding description: Patient and the person who evaluate the treatment outcomes will be blind to the patient's groups. During the first visit, patients will be explained about the probability of being chosen for any of the groups. Before treatment sessions, one of the staff who is not involved in the research will extract the patient information from a sealed envelope and will deliver the laser device's parameters to an operator who either is not involved in the research. Patients and the practitioner won't be informed about the method which has been used. The device's sound is similar for both groups and all patients will be blindfolded by the security eyewear. N/A Temporomandibular Joint Fracture. Intervention 1: Intervention group: Gallium–Aluminum–Arsenide laser, 808nm, 3J/cm3, 20 s sessions of laser therapy will be performed while the probe tip has aproximately 2mm distance from skin surface, on 14 extra oral points (8 points on masseter, 2 poin in pre auricular are, 2 submandibular and 2 point in jugulodigastric area). each time an area of 1.5 mm2 will be treated. Intervention 2: Control group: Intervention in this group will be the same as the intervention1 except the device will be used in inactive mode. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome only When: 6 month after publication To whom: For academic use will be accessible Conditions: For further research Where to obtain: Email: a.bahari@kmu.ac.ir How to obtain: Requests must be applied by Email. Comments:
public Arash Bahari Bandari
Shahid Bahonar HOSP. Qarani St.
kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 arash.bahari@gmail.com Kerman University of Medical Sciences scientific Arash Bahari Bandari
Qarani St
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 arash.bahari@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Trauma patients whith TMJ fracture that need cosed reduction(archbar and maxillomandibular fixation). 18 years no limit Both Subcondylar fractures that need Open Reduction and Internal Fracture(ORIF) Pathologic fractures Patient who cannot complete follow-up sessions Patient with craniafacial deformity Pregnant woman Patien that aren't bale to fill in questionnaire Patients who suffer from major associated traumatic injuries or systemic conditions. S02.92XA Unspecified fracture of facial bones, initial encounter for closed fracture Treatment - Devices Placebo Intervention group: Gallium–Aluminum–Arsenide laser, 808nm, 3J/cm3, 20 s sessions of laser therapy will be performed while the probe tip has aproximately 2mm distance from skin surface, on 14 extra oral points (8 points on masseter, 2 poin in pre auricular are, 2 submandibular and 2 point in jugulodigastric area). each time an area of 1.5 mm2 will be treated. Control group: Intervention in this group will be the same as the intervention1 except the device will be used in inactive mode. Acute postoperative pain in a patient who have undergone a close reduction of temporomandibular joint fracture. Timepoint: VAS will be recorded 24, 48 and 72 hours after surgery. Method of measurement: Visual Analogue scale. Degree of mouth opening. Timepoint: 7 days after surgery. Method of measurement: ruller. Kerman University of Medical Sciences Approved 2020-06-09 Ethics committee of Kerman University of Medical aciences.ical science kerman University of Medical Science, Medical University Campus, Haftbagh ighway, Kerman, Iran kerman Kerman Iran (Islamic Republic of)