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IRCT20180507039576N1 IRCT 2021-06-18 Yazd University of Medical Sciences Effect of cinopar in mandibular fracture Evaluation of the effect of teriparatide (cinopar)on bone healing in mandibular fracture 2021-05-22 anticipated 30 Complete https://irct.ir/trial/55637 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, 30 patients with mandibular fractures are randomly divided into two groups of 15 patients. Patients in the intervention group receive cinopar ampoule (8 micrograms per kilogram daily for one month) in addition to routine drug therapy and the control group only receive routine medication, Randomization description: Patients will be randomly divided into two groups using random number table. This table is a set of numbers. Numbers 1 to 15 will be considered for the intervention group and numbers 16 to 30 for the control group. We will select one of the numbers and move in one of the directions, then the numbers will be recorded and assign to one of the groups, Blinding description: In this study, the person who provided these drugs to patients had no information about the allocation of patients to intervention or control group. 3 Mandibular bone fracture. Intervention 1: Intervention group:In this group, in addition to routine drug therapy, cinopar ampoule (8 micrograms per kilogram daily for one month) which is produced by Cinnagen company is injected subcutaneously in the area around the navel or arm. Intervention 2: Control group: They receive only routine treatment, including antibiotics and analgesics. Yes - There is a plan to make this available What will be shared: Total data When: Access time 6 months after the results are published To whom: All researchers Conditions: Documentation and statistical analysis are made available to all researchers for larger research projects or other studies. Where to obtain: Researcher email : Ebrahimi_6920@yahoo.com How to obtain: Immediately after sending the request by email Comments: If necessary, call the number: 00989151365961
public Somayyeh Ebrahimi
No.301, Infont of Iraj Mirza Ave .,Moalem Blvd ., kashmar Town
Kashmar Iran (Islamic Republic of) ۹۶۷۱۹۹۹۵۱۸ +98 51 8223 2306 Ebrahimi_6920@yahoo.com Yazd University of Medical Sciences scientific Alireza Navab Azam
No.41.,Fourth dead end., Golha alley., Shahid Beheshti Blvd.,Yazd Town
Yazd Iran (Islamic Republic of) 8916666596 +98 35 3626 0000 Alirezanavabazam266@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) 18-60 year Mandibular fracture Open reduction and internal fixation 18 years 60 years Both Infection Patient with a history of fracture Patient taking immunosuppressive, corticosteroid and digoxin The level of calcium greater than 10 S02.60 Fracture of mandible, unspecified Rehabilitation Rehabilitation Intervention group:In this group, in addition to routine drug therapy, cinopar ampoule (8 micrograms per kilogram daily for one month) which is produced by Cinnagen company is injected subcutaneously in the area around the navel or arm. Control group: They receive only routine treatment, including antibiotics and analgesics Bone healing. Timepoint: Before surgery and one month after surgery. Method of measurement: Evaluated both qualitatively, based on subjective fracture line changes , and quantitatively based on Hounsfield unit . Pain. Timepoint: 7, 14, 21, 28 days after surgery. Method of measurement: Visual Analogue Scale. Swelling. Timepoint: 7, 14, 21, 28 days after surgery. Method of measurement: Examination. Ecchymosis. Timepoint: 7, 14, 21, 28 days after surgery. Method of measurement: Examination. Pus discharge. Timepoint: 7, 14, 21, 28 days after surgery. Method of measurement: Examination. Dehiscence. Timepoint: 7, 14, 21, 28 days after surgery. Method of measurement: Examination. Yazd University of Medical Sciences Approved 2021-03-13 Ethics committee of Shahid Sadoughi University of Medical Sciences Campus of Medical Sciences, Shohadaye Gomnam Blvd, Professor Hesabi Blvd Yazd Yazd Iran (Islamic Republic of)