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IRCT201605073398N4 IRCT 2016-05-20 Vice Chancellor for research of Shahid Sadoghi University of Medical Sciences Compare the conventional method and the method of using three-dimensional printers in reconstruction of the mandibular body and Determine the effect of these methods on Intraoperative and postoperative problems Clinical trial comparing the effect of conventional method and method of use three-dimensional printers on the reconstruction difficulties of the mandibular body during surgery and afterwards 2015-07-23 anticipated 20 Complete https://irct.ir/trial/3481 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 pathologic lesion of mandibular body. Intervention 1: intervention1: In the group using three-dimensional printer, after acquiring a CT scan of axial, coronal and three-dimensional reconstruction views, prototype three-dimensional models of the patient's facial bones are fabricated. Then, while studying the three-dimensional model, required treatment plan is determined and shaping and adapting reconstruction plates on the model, which represents the state of the mandibular bone lesion morphology is done. The pre-shaped and adapted reconstruction plates will be delivered to hospital’s CSR for sterilization. After routine tests surgery is performed. The amount of mouth opening will be measured before surgery. during surgery, after resection of bone lesions, pre-shaped plates are placed at the site of reconstruction; Finally, after placement and fixation of reconstruction plates, surgical site will be sutured to end the surgery. During surgery, the amount of blood loss and duration of the operation is measured in both groups. After surgery, mouth opening and post-operative pain is evaluated in multiple time periods. Also the risk of plate exposure and infection during six months of follow-up will be examined. Intervention 2: intervention2l: In the group using conventional method, CT Scan of axial, coronal and three-dimensional reconstruction views are provided for patients but required treatment plan is determined using only clinical assessment and radiographic evaluation and three-dimensional models will not be manufactured. After routine tests surgery is performed. The amount of mouth opening will be measured before surgery. reconstruction plates are shaped routinely during the surgery and adapted on the bone. Finally, after placement and fixation of reconstruction plates, surgical site will be sutured to end the surgery. During surgery, the amount of blood loss and duration of the operation is measured. After surgery, mouth opening and post-operative pain is evaluated in multiple time periods. Also the risk of plate exposure and infection during six months of follow-up will be examined.
public Dr Mohammad Mahdi Nasiri
Dental School, At the beginning of the Dahe Fajr Street, Emam Khomeini Blvd
Yazd Iran (Islamic Republic of) +98 35 3625 8881 mohamadmahdi.nasiri@gmail.com Shahid Sadoghi University Of Medical Sciences scientific Dr Alireza Navabazam
Dental School, At the beginning of the Dahe Fajr Street, Emam Khomeini Blvd
Yazd Iran (Islamic Republic of) +98 35 3625 8881 navabazam@ssu.ac.ir Shahid Sadoghi University Of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: They all have a benign pathological lesion that only involve unilateral body of the mandible (the distal of canine tooth to the angle of mandible) and require resection and subsequent reconstruction surgical procedure under general anesthesia Exclusion criteria: Systemic problems; kidney defects; neurological and psychological problems; diabetes; hypertension; pregnancy; coagulation problems; use of bisphosphonates; the broad-spectrum antibiotics; corticosteroids and non-steroidal analgesics 20 years 70 years Both D 16.5 Benign neoplasm of bone and articular cartilage Treatment - Surgery Treatment - Surgery intervention1: In the group using three-dimensional printer, after acquiring a CT scan of axial, coronal and three-dimensional reconstruction views, prototype three-dimensional models of the patient's facial bones are fabricated. Then, while studying the three-dimensional model, required treatment plan is determined and shaping and adapting reconstruction plates on the model, which represents the state of the mandibular bone lesion morphology is done. The pre-shaped and adapted reconstruction plates will be delivered to hospital’s CSR for sterilization. After routine tests surgery is performed. The amount of mouth opening will be measured before surgery. during surgery, after resection of bone lesions, pre-shaped plates are placed at the site of reconstruction; Finally, after placement and fixation of reconstruction plates, surgical site will be sutured to end the surgery. During surgery, the amount of blood loss and duration of the operation is measured in both groups. After surgery, mouth opening and post-operative pain is evaluated in multiple time periods. Also the risk of plate exposure and infection during six months of follow-up will be examined. intervention2l: In the group using conventional method, CT Scan of axial, coronal and three-dimensional reconstruction views are provided for patients but required treatment plan is determined using only clinical assessment and radiographic evaluation and three-dimensional models will not be manufactured. After routine tests surgery is performed. The amount of mouth opening will be measured before surgery. reconstruction plates are shaped routinely during the surgery and adapted on the bone. Finally, after placement and fixation of reconstruction plates, surgical site will be sutured to end the surgery. During surgery, the amount of blood loss and duration of the operation is measured. After surgery, mouth opening and post-operative pain is evaluated in multiple time periods. Also the risk of plate exposure and infection during six months of follow-up will be examined. Surgery duration. Timepoint: from preparation of patient until extubation. Method of measurement: Questionnaire. Pain. Timepoint: 2،6،12،24،48،72 hours after surgery. Method of measurement: Questionnaire. Duration of resection of bone and reconstruction of mandible. Timepoint: The onset of bone resection to close the last screw on the reconstruction plate. Method of measurement: Questionnaire. Blood loss. Timepoint: Intraoperative. Method of measurement: Questionnaire. Mouth opening. Timepoint: before surgery,24,48,72 and a week after surgery. Method of measurement: Questionnaire. Vice Chancellor for research of Shahid Sadoghi University of Medical Sciences Approved 2016-05-09 Ethics committee of Shahid Sadoghi University of Medical Sciences Shahid Sadoghi University of Medical Sciences, Western Sadoughi Blvd, Bahonar Square Yazd Iran (Islamic Republic of)