Mandibular Fractures — A Cohort Study for Clinical Evaluation of OmniMax MMF System
Citation(s)
Ansari K, Hamlar D, Ho V, Hilger P, Côté D, Aziz T A comparison of anterior vs posterior isolated mandible fractures treated with intermaxillary fixation screws. Arch Facial Plast Surg. 2011 Jul-Aug;13(4):266-70. doi: 10.1001/archfacial.2011.46.
Ayoub AF, Rowson J Comparative assessment of two methods used for interdental immobilization. J Craniomaxillofac Surg. 2003 Jun;31(3):159-61.
Chao AH, Hulsen J Bone-supported arch bars are associated with comparable outcomes to Erich arch bars in the treatment of mandibular fractures with intermaxillary fixation. J Oral Maxillofac Surg. 2015 Feb;73(2):306-13. doi: 10.1016/j.joms.2014.08.025. Epub 2014 Aug 27.
Coletti DP, Salama A, Caccamese JF Jr Application of intermaxillary fixation screws in maxillofacial trauma. J Oral Maxillofac Surg. 2007 Sep;65(9):1746-50.
Cornelius CP, Ehrenfeld M The Use of MMF Screws: Surgical Technique, Indications, Contraindications, and Common Problems in Review of the Literature. Craniomaxillofac Trauma Reconstr. 2010 Jun;3(2):55-80. doi: 10.1055/s-0030-1254376.
Engelstad ME, Kelly P Embrasure wires for intraoperative maxillomandibular fixation are rapid and effective. J Oral Maxillofac Surg. 2011 Jan;69(1):120-4. doi: 10.1016/j.joms.2010.06.209. Epub 2010 Oct 29.
Fabbroni G, Aabed S, Mizen K, Starr DG Transalveolar screws and the incidence of dental damage: a prospective study. Int J Oral Maxillofac Surg. 2004 Jul;33(5):442-6.
Hashemi HM, Parhiz A Complications using intermaxillary fixation screws. J Oral Maxillofac Surg. 2011 May;69(5):1411-4. doi: 10.1016/j.joms.2010.05.070. Epub 2011 Jan 8.
Ingole PD, Garg A, Shenoi SR, Badjate SJ, Budhraja N Comparison of intermaxillary fixation screw versus eyelet interdental wiring for intermaxillary fixation in minimally displaced mandibular fracture: a randomized clinical study. J Oral Maxillofac Surg. 2014 May;72(5):958.e1-7. doi: 10.1016/j.joms.2014.01.005. Epub 2014 Jan 18.
Laurentjoye M, Majoufre-Lefebvre C, Siberchicot F, Ricard AS Result of maxillomandibular fixation using intraoral cortical bone screws for condylar fractures of the mandible. J Oral Maxillofac Surg. 2009 Apr;67(4):767-70. doi: 10.1016/j.joms.2008.06.055.
Nandini GD, Balakrishna R, Rao J Self Tapping Screws v/s Erich Arch Bar for Inter Maxillary Fixation: A Comparative Clinical Study in the Treatment of Mandibular Fractures. J Maxillofac Oral Surg. 2011 Jun;10(2):127-31. doi: 10.1007/s12663-011-0191-3. Epub 2011 Apr 20.
Park KN, Oh SM, Lee CY, Kim JY, Yang BE Design and application of hybrid maxillomandibular fixation for facial bone fractures. J Craniofac Surg. 2013;24(5):1801-5. doi: 10.1097/SCS.0b013e3182a21163.
Rai A, Datarkar A, Borle RM Are maxillomandibular fixation screws a better option than Erich arch bars in achieving maxillomandibular fixation? A randomized clinical study. J Oral Maxillofac Surg. 2011 Dec;69(12):3015-8. doi: 10.1016/j.joms.2010.12.015. Epub 2011 Apr 5.
Roccia F, Rossi P, Gallesio C, Boffano P Self-tapping and self-drilling screws for intermaxillary fixation in management of mandibular fractures. J Craniofac Surg. 2009 Jan;20(1):68-70. doi: 10.1097/SCS.0b013e318190df2f.
Sahoo NK, Mohan R IMF Screw: An Ideal Intermaxillary Fixation Device During Open Reduction of Mandibular Fracture. J Maxillofac Oral Surg. 2010 Jun;9(2):170-2. doi: 10.1007/s12663-010-0049-0. Epub 2010 Sep 22.
Schulte-Geers M, Kater W, Seeberger R Root trauma and tooth loss through the application of pre-drilled transgingival fixation screws. J Craniomaxillofac Surg. 2012 Oct;40(7):e214-7. doi: 10.1016/j.jcms.2011.10.022. Epub 2011 Nov 17.
Valentino J, Marentette LJ Supplemental maxillomandibular fixation with miniplate osteosynthesis. Otolaryngol Head Neck Surg. 1995 Feb;112(2):215-20.
Vartanian AJ, Alvi A Bone-screw mandible fixation: an intraoperative alternative to arch bars. Otolaryngol Head Neck Surg. 2000 Dec;123(6):718-21.
West GH, Griggs JA, Chandran R, Precheur HV, Buchanan W, Caloss R Treatment outcomes with the use of maxillomandibular fixation screws in the management of mandible fractures. J Oral Maxillofac Surg. 2014 Jan;72(1):112-20. doi: 10.1016/j.joms.2013.08.001. Epub 2013 Sep 25.
The OmniMax MMF System: A Cohort Study for Clinical Evaluation
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
