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IRCT2016022526769N1 IRCT 2016-12-17 Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences Clinical Trial to Comparison of Fracture Healing between Closed Reduction Surgery Alone and in Combination with Pulsed Magnetic Filed in Patients with Mandibular Fracture - Clinical Trial to Comparison of Fracture Healing between Closed Reduction Surgery Alone and in Combination with Pulsed Magnetic Filed in Patients with Mandibular Fracture 2012-03-20 anticipated 32 Complete https://irct.ir/trial/22091 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomizated with Flip the Coin Method. 1-2 Mandible fx. Intervention 1: Intervention group: In this group, fracture sites expose to pulsed electromagnetic fields (PEMF) for 6 hours immediately after surgery. Then, this procedure will repeat on the 7th day for 3 hours and on the 14th day for 1.5 hours. The MMF (mandibular fixation) will be removed at fourth weeks after surgery. Intervention 2: Control group: Only treatment of Mandibular fracture with closed reduction method. The MMF will be removed at sixth weeks.
public Dr. Hassan Mohajerani
Dental School, Shahid Beheshti University of Medical Sciences, Daneshjoo Sq., Evin st., Tehran-Iran.
Tehran Iran (Islamic Republic of) +98 21 2222 8511 Mohajeranih@gmail.com Dental School, Shahid Beheshti University of Medical Sciences. scientific Dr. Hassan Mohajerani
Dental School, Shahid Beheshti University of Medical Sciences, Daneshjoo Sq., Evin st., Tehran-Iran.
Tehran Iran (Islamic Republic of) +98 21 2222 8511 Mohajeranih@gmail.com Dental School, Shahid Beheshti University of Medical Sciences. Iran (Islamic Republic of) Inclusion criteria included the consent of participating in study, mandible fracture in dental region, existence of enough dental contacts in both sides of fracture line that possibility of application of arch bar and maxillary mandibular fixation (MMF) establishment exists, absence of signs of infection in fracture region, lack of systemic diseases affecting favorable stages of bone regeneration, treatment indications of closed reduction. Exclusion criteria included lack of consent of participating in study and contraindications of closed reduction treatment no limit no limit Both S02.6 Lower jaw (bone) Other Treatment - Surgery Intervention group: In this group, fracture sites expose to pulsed electromagnetic fields (PEMF) for 6 hours immediately after surgery. Then, this procedure will repeat on the 7th day for 3 hours and on the 14th day for 1.5 hours. The MMF (mandibular fixation) will be removed at fourth weeks after surgery. Control group: Only treatment of Mandibular fracture with closed reduction method. The MMF will be removed at sixth weeks. Changes in bone mineral density. Timepoint: Befor Operation, 2 weeks & 4 weeks later. Method of measurement: Radio densitometry. The post-operative pain. Timepoint: Operation Day, One day later & one week & two weeks later. Method of measurement: Visual Analog Scale (VAS). The maximum amount of open mouth. Timepoint: End of treatment. Method of measurement: Caliper Vrnyr. Sensory changes. Timepoint: Prior to operation, a month later, two months later. Method of measurement: Patient verbal affirmation of abnormal lip sensation. Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences Approved 2016-07-02 Ettichs Committe of Shahid Beheshti University of Medical Sciences Ettichs Committe, Shahid Beheshti University of Medical Sciences, Daneshjoo Sq., Evin st., Tehran-Iran. Tehran Iran (Islamic Republic of)